NCT02960490 is a Phase 2 clinical trial of E6011 in Rheumatoid Arthritis, sponsored by Eisai Co., Ltd..

Who is sponsoring NCT02960490?

NCT02960490 is sponsored by Eisai Co., Ltd..

What drugs are being tested in NCT02960490?

Interventions in NCT02960490: E6011, Placebo.

What condition does NCT02960490 study?

NCT02960490 studies Rheumatoid Arthritis.

Is NCT02960490 still recruiting?

NCT02960490 is currently completed. Last updated 23 August 2021.

Are results published for NCT02960490?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-23 · How we verify

NCT02960490

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics

Completed Phase 2 Results posted Last updated 23 August 2021

What this trial tests

Phase 2 trial testing E6011 in Rheumatoid Arthritis in 66 participants. Completed in 25 November 2019.

Timeline

26 November 2016

Primary endpoint
16 May 2018

25 November 2019

Quick facts

Lead sponsor	Eisai Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	66
Start date	26 November 2016
Primary completion	16 May 2018
Estimated completion	25 November 2019
Sites	45 locations across Japan

Drugs / interventions tested

E6011 — full drug profile →
Placebo

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Eisai Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI) Primary · Week 12

The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (\>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); \>=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale \[VAS\]), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability i

Group	Value	95% CI
Core Treatment Phase: Placebo	27.3	12.08 – 42.47
Core Treatment Phase: E6011 400 mg	22.6	7.86 – 37.30

Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Secondary · Core Treatment Phase: Weeks 2, 4, 8, 16, 20, 24; Extension Phase: Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The ACR20 response was defined as if the following 3 criteria (ACR components) were met: \>=20% reduction from baseline in the TJC in 68 joints (TJC68); \>=20% reduction from baseline in the SJC in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12.

Response at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	13.3	0.00 – 30.54
Core Treatment Phase: Placebo Then E6011 400 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	25.0	0.50 – 49.50
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	15.4	0.00 – 35.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	9.1	0.00 – 26.08
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	20.0	0.00 – 44.79

Response at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	13.3	0.00 – 30.54
Core Treatment Phase: Placebo Then E6011 400 mg	28.6	4.91 – 52.24
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	28.6	4.91 – 52.24
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	8.3	0.00 – 23.97
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	15.4	0.00 – 35.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	27.3	0.95 – 53.59
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	30.8	5.68 – 55.86
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	10.0	0.00 – 28.59

Response at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	20.0	0.00 – 40.24
Core Treatment Phase: Placebo Then E6011 400 mg	28.6	4.91 – 52.24
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	35.7	10.61 – 60.81
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	25.0	0.50 – 49.50
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	23.1	0.17 – 45.98
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	27.3	0.95 – 53.59
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	38.5	12.02 – 64.91
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	30.0	1.60 – 58.40

Response at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	26.7	4.29 – 49.05
Core Treatment Phase: Placebo Then E6011 400 mg	28.6	4.91 – 52.24
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	42.9	16.93 – 68.78
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	50.0	21.71 – 78.29
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	30.8	5.68 – 55.86
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	36.4	7.94 – 64.79
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	46.2	19.05 – 73.25
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	60.0	29.64 – 90.36

Response at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	46.7	21.42 – 71.91
Core Treatment Phase: Placebo Then E6011 400 mg	35.7	10.61 – 60.81
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	28.6	4.91 – 52.24
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	50.0	21.71 – 78.29
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	53.8	26.75 – 80.95
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	45.5	16.03 – 74.88
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	30.8	5.68 – 55.86
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	50.0	19.01 – 80.99

Response at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	46.7	21.42 – 71.91
Core Treatment Phase: Placebo Then E6011 400 mg	28.6	4.91 – 52.24
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	21.4	0.00 – 42.92
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	33.3	6.66 – 60.01
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	53.8	26.75 – 80.95
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	36.4	7.94 – 64.79
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	23.1	0.17 – 45.98
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	30.0	1.60 – 58.40

Response at Week 28

Group	Value	95% CI
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	53.8	26.75 – 80.95
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	54.5	25.12 – 83.97
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	38.5	12.02 – 64.91
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	50.0	19.01 – 80.99

Response at Week 32

Group	Value	95% CI
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	61.5	35.09 – 87.98
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	36.4	7.94 – 64.79
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	38.5	12.02 – 64.91
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	50.0	19.01 – 80.99

Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Secondary · Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The ACR50 response was defined as if the following 3 criteria (ACR components) were met: \>=50% reduction from baseline in the TJC in 68 joints (TJC68); \>=50% reduction from baseline in the SJC in 66 joints (SJC66); \>=50% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12.

Response at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	14.3	0.00 – 32.62
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	18.2	0.00 – 40.97
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	14.3	0.00 – 32.62
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	18.2	0.00 – 40.97
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	16.7	0.00 – 37.75
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	9.1	0.00 – 26.08
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	20.0	0.00 – 44.79

Response at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	16.7	0.00 – 37.75
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	20.0	0.00 – 44.79

Response at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	20.0	0.00 – 40.24
Core Treatment Phase: Placebo Then E6011 400 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	16.7	0.00 – 37.75
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	23.1	0.17 – 45.98
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	9.1	0.00 – 26.08
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	20.0	0.00 – 44.79

Response at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	20.0	0.00 – 40.24
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	16.7	0.00 – 37.75
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	23.1	0.17 – 45.98
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	20.0	0.00 – 44.79

Response at Week 28

Group	Value	95% CI
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	30.8	5.68 – 55.86
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	18.2	0.00 – 40.97
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	15.4	0.00 – 35.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	30.0	1.60 – 58.40

Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI Secondary · Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The ACR70 response was defined as if the following 3 criteria (ACR components) were met: \>=70% reduction from baseline in the TJC in 68 joints (TJC68); \>=70% reduction from baseline in the SJC in 66 joints (SJC66); \>=70% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12.

Response at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	9.1	0.00 – 26.08
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	7.1	0.00 – 20.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	7.7	0.00 – 22.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	8.3	0.00 – 23.97
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	10.0	0.00 – 28.59

Response at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.0	0.00 – 0.00
Core Treatment Phase: Placebo Then E6011 400 mg	0.0	0.00 – 0.00
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.0	0.0 – 0.0
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.0	0.0 – 0.0
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.0	0.00 – 0.00

Response at Week 28

Group	Value	95% CI
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	18.2	0.00 – 40.97
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.0	0.00 – 0.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	10.0	0.00 – 28.59

Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

A total of 28 joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Tender joints were marked with tick or cross in corresponding frames of the Assessment Sheet for Tender Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Wee

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	9.7	± 6.88
Core Treatment Phase: Placebo Then E6011 400 mg	11.7	± 7.74
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	9.9	± 4.80
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	12.8	± 7.58
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	8.7	± 4.85
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	11.6	± 8.67
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	9.5	± 4.75
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	10.3	± 5.10

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-1.6	± 3.92
Core Treatment Phase: Placebo Then E6011 400 mg	-1.3	± 3.41
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-1.9	± 4.48
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-4.4	± 5.52
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-2.0	± 4.06
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-1.3	± 3.77
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.0	± 4.65
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-3.0	± 4.83

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-2.8	± 6.07
Core Treatment Phase: Placebo Then E6011 400 mg	-2.9	± 5.11
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-2.3	± 5.81
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-5.1	± 6.16
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-3.2	± 6.48
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-3.1	± 5.74
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-1.8	± 5.80
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-3.9	± 5.92

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-3.3	± 5.51
Core Treatment Phase: Placebo Then E6011 400 mg	-2.9	± 8.89
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-1.9	± 6.18
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-5.8	± 3.05
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-3.5	± 5.91
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-3.8	± 9.72
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-1.3	± 6.06
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-5.2	± 2.97

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-2.7	± 5.59
Core Treatment Phase: Placebo Then E6011 400 mg	-2.1	± 8.75
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-2.0	± 6.11
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-6.2	± 3.86
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-3.1	± 5.92
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-3.5	± 9.05
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-1.8	± 6.30
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-6.1	± 4.20

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-4.3	± 6.65
Core Treatment Phase: Placebo Then E6011 400 mg	-4.1	± 5.17
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-2.9	± 5.73
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-7.5	± 6.97
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-4.5	± 7.15
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-4.8	± 5.38
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.6	± 5.84
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-6.5	± 5.72

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-4.9	± 6.06
Core Treatment Phase: Placebo Then E6011 400 mg	-4.1	± 7.19
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-2.9	± 6.46
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-8.2	± 7.30
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-5.2	± 6.48
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-4.9	± 7.82
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.8	± 6.72
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-6.3	± 4.16

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-5.1	± 5.63
Core Treatment Phase: Placebo Then E6011 400 mg	-3.7	± 8.30
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-2.6	± 6.06
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-7.8	± 8.07
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-5.5	± 5.99
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-3.9	± 9.81
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.5	± 6.29
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-6.2	± 6.89

Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

A total of 28 joints were examined for swollen joints. Swollen joints were marked with open circles in corresponding frames of the Assessment Sheet for Swollen Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	7.1	± 2.91
Core Treatment Phase: Placebo Then E6011 400 mg	9.5	± 6.14
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	8.9	± 3.47
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	8.8	± 4.39
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	7.0	± 2.97
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	9.5	± 6.98
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	9.2	± 3.51
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	7.6	± 3.37

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-2.7	± 2.99
Core Treatment Phase: Placebo Then E6011 400 mg	-2.6	± 2.31
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-2.0	± 2.86
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-3.3	± 4.69
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-2.7	± 3.17
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-2.7	± 2.57
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.2	± 2.91
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-2.6	± 4.77

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-2.3	± 3.73
Core Treatment Phase: Placebo Then E6011 400 mg	-3.7	± 3.95
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-1.8	± 3.60
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-3.9	± 4.14
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-2.4	± 3.75
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-3.5	± 4.44
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-1.9	± 3.71
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-3.9	± 4.48

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-3.3	± 3.33
Core Treatment Phase: Placebo Then E6011 400 mg	-4.8	± 6.38
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.8	± 4.54
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-4.8	± 4.15
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-3.5	± 3.33
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-5.1	± 7.20
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.8	± 4.72
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-5.0	± 4.57

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-2.9	± 3.95
Core Treatment Phase: Placebo Then E6011 400 mg	-4.2	± 6.40
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-2.5	± 4.01
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-4.3	± 4.61
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-3.5	± 3.95
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-4.5	± 7.22
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.8	± 4.04
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-4.2	± 4.83

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-3.2	± 4.06
Core Treatment Phase: Placebo Then E6011 400 mg	-5.4	± 5.45
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-1.9	± 4.57
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-5.3	± 4.63
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-3.5	± 3.95
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-5.6	± 6.17
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-1.9	± 4.75
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-5.1	± 4.75

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-3.3	± 4.60
Core Treatment Phase: Placebo Then E6011 400 mg	-5.8	± 6.10
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-1.4	± 4.82
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-5.8	± 4.34
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-3.2	± 4.76
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-6.0	± 6.65
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-1.4	± 4.82
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-5.5	± 4.22

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-3.9	± 4.45
Core Treatment Phase: Placebo Then E6011 400 mg	-5.4	± 7.26
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.6	± 5.65
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-4.0	± 3.79
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-4.4	± 4.33
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-4.9	± 8.97
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.8	± 5.83
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-4.1	± 4.18

Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Intensity and severity of pain associated with rheumatoid arthritis (RA) were indicated by the participant on a score sheet, Pain/disease activity assessments reported by the participant, by placing a mark on a 100 millimeter (mm) horizontal VAS. Pain assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported accord

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	56.7	± 32.02
Core Treatment Phase: Placebo Then E6011 400 mg	55.9	± 30.33
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	56.9	± 33.07
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	60.3	± 20.78
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	57.5	± 28.43
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	52.5	± 29.96
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	54.2	± 32.67
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	56.4	± 18.78

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-5.7	± 15.50
Core Treatment Phase: Placebo Then E6011 400 mg	-3.3	± 15.47
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-3.3	± 22.53
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-4.8	± 19.07
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-7.4	± 15.71
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-3.4	± 17.57
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-3.0	± 23.42
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-1.9	± 19.67

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-9.8	± 16.50
Core Treatment Phase: Placebo Then E6011 400 mg	-13.4	± 26.58
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-8.4	± 21.23
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-6.3	± 17.61
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-11.2	± 17.32
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-12.0	± 27.40
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-7.5	± 21.82
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-8.8	± 18.18

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-13.9	± 18.95
Core Treatment Phase: Placebo Then E6011 400 mg	-14.2	± 30.92
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-9.6	± 21.94
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-12.6	± 14.88
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-14.7	± 19.04
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-12.8	± 34.33
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-7.5	± 21.19
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-14.1	± 15.81

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-8.5	± 25.01
Core Treatment Phase: Placebo Then E6011 400 mg	-8.0	± 24.10
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-15.1	± 18.89
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-16.8	± 20.23
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-9.5	± 23.09
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-7.6	± 26.27
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-14.2	± 19.33
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-16.4	± 18.84

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-15.7	± 23.03
Core Treatment Phase: Placebo Then E6011 400 mg	-9.8	± 18.35
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-18.5	± 22.70
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-15.9	± 14.77
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-16.4	± 24.02
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-11.4	± 20.57
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-17.8	± 23.49
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-14.7	± 12.96

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-18.4	± 28.02
Core Treatment Phase: Placebo Then E6011 400 mg	-9.2	± 15.57
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-14.7	± 23.67
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-17.7	± 16.88
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-22.8	± 23.35
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-9.5	± 16.32
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-15.0	± 24.61
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-14.2	± 13.38

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-17.4	± 27.91
Core Treatment Phase: Placebo Then E6011 400 mg	-8.4	± 18.57
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-20.0	± 28.15
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-14.9	± 14.69
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-21.6	± 23.42
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-9.9	± 20.54
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-20.7	± 29.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-12.9	± 14.65

Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Participants were evaluated on their disease activity of RA, and entered the result on the score sheet, disease activity assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24,

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	56.2	± 31.20
Core Treatment Phase: Placebo Then E6011 400 mg	54.9	± 32.83
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	55.6	± 34.74
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	57.7	± 20.12
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	57.2	± 27.56
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	51.0	± 32.93
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	52.3	± 33.74
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	53.9	± 18.43

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-1.4	± 10.52
Core Treatment Phase: Placebo Then E6011 400 mg	-4.1	± 13.20
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-4.6	± 20.66
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-4.7	± 14.21
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-2.6	± 10.59
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-4.2	± 14.70
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-3.6	± 21.18
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-2.7	± 14.71

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-8.1	± 16.76
Core Treatment Phase: Placebo Then E6011 400 mg	-12.7	± 25.46
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-7.4	± 24.36
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-3.9	± 14.72
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-9.3	± 17.76
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-11.5	± 25.73
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-5.5	± 24.34
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-7.0	± 13.75

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-11.5	± 19.27
Core Treatment Phase: Placebo Then E6011 400 mg	-13.4	± 29.22
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-8.9	± 24.79
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-14.8	± 16.50
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-12.3	± 19.83
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-11.6	± 32.31
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-6.0	± 23.28
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-13.4	± 15.37

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-7.2	± 25.53
Core Treatment Phase: Placebo Then E6011 400 mg	-6.9	± 23.69
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-13.1	± 22.86
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-13.1	± 20.03
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-8.5	± 24.24
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-5.8	± 24.73
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-12.2	± 23.48
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-13.9	± 18.33

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-15.0	± 25.59
Core Treatment Phase: Placebo Then E6011 400 mg	-7.4	± 18.94
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-14.1	± 24.07
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-13.5	± 17.73
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-16.2	± 27.05
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-9.5	± 20.91
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-13.6	± 24.99
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-13.0	± 18.05

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-16.7	± 27.33
Core Treatment Phase: Placebo Then E6011 400 mg	-8.4	± 14.28
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-12.7	± 26.93
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-16.8	± 20.74
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-20.9	± 24.16
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-9.4	± 15.21
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-12.4	± 28.00
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-13.6	± 19.38

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-15.9	± 27.17
Core Treatment Phase: Placebo Then E6011 400 mg	-8.8	± 16.43
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-16.3	± 27.10
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-12.3	± 13.50
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-20.0	± 24.13
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-10.8	± 17.92
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-16.2	± 28.20
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-11.3	± 14.59

Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's RA disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	63.3	± 29.63
Core Treatment Phase: Placebo Then E6011 400 mg	57.9	± 22.02
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	62.4	± 19.41
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	54.0	± 27.28
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	60.8	± 30.56
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	56.4	± 22.41
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	60.5	± 18.80
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	49.6	± 27.15

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-16.8	± 16.83
Core Treatment Phase: Placebo Then E6011 400 mg	-13.6	± 17.95
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-13.3	± 23.08
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-8.1	± 18.53
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-15.6	± 17.52
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-16.8	± 17.66
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-13.9	± 23.89
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-6.6	± 20.13

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-20.7	± 13.62
Core Treatment Phase: Placebo Then E6011 400 mg	-16.8	± 19.68
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-17.8	± 27.46
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-10.1	± 16.68
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-18.2	± 12.60
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-16.7	± 16.88
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-17.7	± 28.58
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-12.7	± 17.13

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-23.8	± 26.32
Core Treatment Phase: Placebo Then E6011 400 mg	-17.6	± 21.57
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-19.6	± 27.81
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-13.8	± 18.01
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-17.7	± 22.40
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-17.7	± 20.60
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-20.3	± 28.83
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-14.6	± 19.79

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-23.3	± 26.50
Core Treatment Phase: Placebo Then E6011 400 mg	-9.4	± 21.99
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-19.0	± 30.18
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-14.7	± 21.15
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-20.5	± 24.71
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-11.5	± 20.62
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-20.8	± 30.65
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-17.2	± 22.32

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-28.4	± 30.15
Core Treatment Phase: Placebo Then E6011 400 mg	-19.7	± 20.22
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-23.4	± 29.34
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-14.5	± 23.89
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-23.6	± 29.57
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-23.1	± 20.53
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-24.5	± 30.19
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-16.7	± 25.66

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-28.9	± 25.67
Core Treatment Phase: Placebo Then E6011 400 mg	-24.3	± 22.97
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-20.6	± 27.81
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-19.1	± 20.38
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-25.9	± 25.94
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-30.2	± 20.74
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-21.7	± 28.61
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-19.7	± 19.93

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-36.7	± 30.38
Core Treatment Phase: Placebo Then E6011 400 mg	-18.3	± 21.35
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-17.6	± 26.03
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-10.0	± 23.18
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-34.8	± 32.06
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-22.6	± 20.34
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-18.5	± 26.87
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-8.9	± 23.36

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

Degree of disability was self-evaluated by participant using HAQ-DI.Assessment was made based on activities capable without any aids/devices.20-question instrument assessed degree of difficulty person had in accomplishing tasks in 8 functional areas(dressing,arising,eating,walking,hygiene,reaching,gripping,and activities of daily living).Responses in each functional area were scored from 0(indicated no difficulty)to 3(indicated inability to perform task in that area).Overall score computed as: sum of domain scores and divided by number of domains answered.Total possible score range:0-3 where 0

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.90	± 0.816
Core Treatment Phase: Placebo Then E6011 400 mg	1.04	± 0.770
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.88	± 0.744
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	1.08	± 0.673
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.85	± 0.702
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	1.20	± 0.789
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.76	± 0.605
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.94	± 0.607

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.07	± 0.163
Core Treatment Phase: Placebo Then E6011 400 mg	-0.03	± 0.399
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.08	± 0.297
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.01	± 0.258
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.07	± 0.174
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.08	± 0.423
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.04	± 0.262
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.00	± 0.270

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.03	± 0.197
Core Treatment Phase: Placebo Then E6011 400 mg	-0.25	± 0.460
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.10	± 0.371
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-0.03	± 0.316
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.02	± 0.203
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.30	± 0.485
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.05	± 0.333
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-0.05	± 0.334

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-0.04	± 0.181
Core Treatment Phase: Placebo Then E6011 400 mg	-0.38	± 0.595
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.10	± 0.344
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-0.05	± 0.404
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-0.07	± 0.174
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.47	± 0.647
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.09	± 0.355
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-0.10	± 0.428

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.12	± 0.358
Core Treatment Phase: Placebo Then E6011 400 mg	-0.25	± 0.357
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.06	± 0.459
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-0.02	± 0.497
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.10	± 0.369
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.34	± 0.340
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.07	± 0.478
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-0.04	± 0.507

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.03	± 0.376
Core Treatment Phase: Placebo Then E6011 400 mg	-0.11	± 0.395
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.11	± 0.495
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-0.04	± 0.421
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.02	± 0.405
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.22	± 0.354
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.13	± 0.510
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-0.04	± 0.457

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-0.04	± 0.400
Core Treatment Phase: Placebo Then E6011 400 mg	-0.21	± 0.341
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.15	± 0.619
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-0.02	± 0.579
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-0.07	± 0.426
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.30	± 0.341
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.19	± 0.624
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.04	± 0.604

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-0.04	± 0.483
Core Treatment Phase: Placebo Then E6011 400 mg	-0.23	± 0.395
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.23	± 0.574
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.02	± 0.464
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	-0.07	± 0.517
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.33	± 0.388
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.28	± 0.569
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.04	± 0.510

Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

CRP of each participants was measured as a part of blood biochemical tests. A normal CRP value is less than (\<) 10 milligram per deciliter (mg/dL). A test result showing a CRP level greater than 10 mg/dL is a sign of chronic disease. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose prim

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	1.08	± 1.299
Core Treatment Phase: Placebo Then E6011 400 mg	2.50	± 4.012
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	3.09	± 3.186
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	1.68	± 2.504
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.94	± 1.097
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	1.83	± 2.893
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	3.10	± 3.316
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.81	± 0.736

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.47	± 0.795
Core Treatment Phase: Placebo Then E6011 400 mg	0.02	± 1.701
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.39	± 1.438
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	-0.13	± 0.870
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.46	± 0.855
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.23	± 1.782
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.45	± 1.473
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-0.11	± 0.277

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.18	± 0.507
Core Treatment Phase: Placebo Then E6011 400 mg	-0.63	± 2.308
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.25	± 0.938
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.73	± 3.043
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.23	± 0.525
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.01	± 0.636
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.30	± 0.957
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-0.02	± 0.239

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	-0.06	± 0.579
Core Treatment Phase: Placebo Then E6011 400 mg	-0.33	± 2.229
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.09	± 1.277
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.43	± 1.644
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.05	± 0.389
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.30	± 0.518
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.20	± 1.262
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.07	± 0.680

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.15	± 0.978
Core Treatment Phase: Placebo Then E6011 400 mg	-0.44	± 1.643
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.07	± 2.524
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.40	± 1.618
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.32	± 0.814
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.18	± 0.810
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.02	± 2.618
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.33	± 1.048

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.05	± 1.090
Core Treatment Phase: Placebo Then E6011 400 mg	-0.42	± 1.755
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.08	± 1.943
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.63	± 2.343
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.22	± 0.965
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.10	± 0.835
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.09	± 1.909
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.28	± 0.870

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.19	± 1.278
Core Treatment Phase: Placebo Then E6011 400 mg	-0.41	± 1.792
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	0.49	± 2.713
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.56	± 2.257
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.36	± 1.180
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-0.10	± 0.849
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	0.35	± 2.771
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.37	± 0.660

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	0.21	± 1.144
Core Treatment Phase: Placebo Then E6011 400 mg	-0.31	± 1.692
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.49	± 2.893
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	0.47	± 2.047
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	0.38	± 1.004
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.15	± 0.652
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.71	± 2.892
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.65	± 1.682

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Secondary · Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72

ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.

Baseline

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	33.1	± 19.55
Core Treatment Phase: Placebo Then E6011 400 mg	44.4	± 25.70
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	51.8	± 34.26
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	35.3	± 18.44
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	33.9	± 19.56
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	41.2	± 25.81
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	49.9	± 34.91
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	32.3	± 18.89

Change at Week 2

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	8.1	± 14.36
Core Treatment Phase: Placebo Then E6011 400 mg	0.2	± 12.43
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	1.5	± 11.63
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	1.5	± 10.28
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	8.6	± 15.37
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-1.2	± 13.39
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.8	± 8.28
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-1.9	± 6.54

Change at Week 4

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	8.6	± 14.66
Core Treatment Phase: Placebo Then E6011 400 mg	2.1	± 18.56
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.3	± 11.56
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	1.4	± 15.41
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	9.5	± 15.59
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	1.5	± 16.66
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.9	± 11.77
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-4.0	± 9.59

Change at Week 8

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	4.2	± 9.53
Core Treatment Phase: Placebo Then E6011 400 mg	5.4	± 15.78
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.5	± 17.72
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	3.9	± 21.68
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	4.6	± 10.21
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	3.5	± 14.36
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.3	± 17.05
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	-2.6	± 16.87

Change at Week 12

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	1.8	± 10.14
Core Treatment Phase: Placebo Then E6011 400 mg	5.1	± 23.65
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-1.5	± 22.06
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	6.8	± 19.60
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	2.1	± 10.80
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	4.7	± 21.64
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-3.8	± 21.06
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	4.5	± 20.74

Change at Week 16

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	4.7	± 10.64
Core Treatment Phase: Placebo Then E6011 400 mg	-3.4	± 14.11
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-3.0	± 23.33
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	3.0	± 23.46
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	5.8	± 10.90
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-3.4	± 15.64
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-3.5	± 24.22
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	0.8	± 23.29

Change at Week 20

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	2.3	± 12.72
Core Treatment Phase: Placebo Then E6011 400 mg	-0.4	± 11.04
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	1.2	± 31.07
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	6.9	± 18.59
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	2.8	± 13.45
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	0.6	± 11.96
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-0.8	± 31.33
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	2.7	± 16.91

Change at Week 24

Group	Value	95% CI
Core Treatment Phase: Placebo Then E6011 200 mg	8.2	± 17.51
Core Treatment Phase: Placebo Then E6011 400 mg	-2.7	± 14.74
Core Treatment Phase: E6011 400 mg Then E6011 200 mg	-0.1	± 33.28
Core Treatment Phase: E6011 400 mg Then E6011 400 mg	9.3	± 19.00
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg	9.6	± 18.32
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg	-2.4	± 16.48
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg	-2.3	± 33.60
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg	4.5	± 15.46

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Core Treatment Phase: Placebo

Serious: 1/33 (3%)

Deaths: 0/33

Core Treatment Phase: E6011 400 mg

Serious: 0/31 (0%)

Deaths: 0/31

Core Treatment Phase: Placebo Then E6011 200 mg

Serious: 0/15 (0%)

Deaths: 0/15

Core Treatment Phase: Placebo Then E6011 400 mg

Serious: 1/14 (7%)

Deaths: 0/14

Core Treatment Phase: E6011 400 mg Then E6011 200 mg

Serious: 0/14 (0%)

Deaths: 0/14

Core Treatment Phase: E6011 400 mg Then E6011 400 mg

Serious: 0/12 (0%)

Deaths: 0/12

Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg

Serious: 2/13 (15%)

Deaths: 1/13

Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg

Serious: 2/11 (18%)

Deaths: 0/11

Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg

Serious: 2/13 (15%)

Deaths: 0/13

Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg

Serious: 0/10 (0%)

Deaths: 0/10

Serious adverse events (9 terms)

Reaction	System	Core Treatment Phase: Plac…	Core Treatment Phase: E601…	Core Treatment Phase: Plac…	Core Treatment Phase: Plac…	Core Treatment Phase: E601…	Core Treatment Phase: E601…	Extension Phase: Placebo T…	Extension Phase: Placebo T…	Extension Phase: E6011 400…	Extension Phase: E6011 400…
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Oesophageal achalasia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Sudden death	General disorders	—	—	—	—	—	—	—	—	—	—
Joint destruction	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Osteoporosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—

Other adverse events (115 terms — click to expand)

Reaction	System	Core Treatment Phase: Plac…	Core Treatment Phase: E601…	Core Treatment Phase: Plac…	Core Treatment Phase: Plac…	Core Treatment Phase: E601…	Core Treatment Phase: E601…	Extension Phase: Placebo T…	Extension Phase: Placebo T…	Extension Phase: E6011 400…	Extension Phase: E6011 400…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Periodontal disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—	—	—	—
Paronychia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Tinea pedis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Eustachian tube patulous	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Faeces soft	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Cheilitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Mouth ulceration	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—	—	—	—
Face oedema	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site warmth	General disorders	—	—	—	—	—	—	—	—	—	—
Breast abscess	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Cholecystitis acute, Hepatic function abnormal, Tendon rupture, Oesophageal achalasia, Sudden death, Joint destruction, Osteoarthritis, Osteoporosis.

Data from ClinicalTrials.gov NCT02960490 adverse events section.

Sponsor's own description

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study in rheumatoid arthritis participants inadequately responding to biologics.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Emerging Role of Fractalkine in the Treatment of Rheumatic Diseases.
Tanaka Y, Hoshino-Negishi K, Kuboi Y, Tago F, et al · · 2020 · cited 27× · PMID 33178636 · DOI 10.2147/itt.s277991

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02960490 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Co., Ltd.
Last refreshed: 23 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02960490.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02960490

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (9 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of E6011

Other recruiting trials for Rheumatoid Arthritis

Other Eisai Co., Ltd. trials

Verify against primary sources