NCT02960438 is a Phase 2 clinical trial of E6011 in Rheumatoid Arthritis, sponsored by Eisai Co., Ltd..

Who is sponsoring NCT02960438?

NCT02960438 is sponsored by Eisai Co., Ltd..

What drugs are being tested in NCT02960438?

Interventions in NCT02960438: E6011, Placebo.

What condition does NCT02960438 study?

NCT02960438 studies Rheumatoid Arthritis.

Is NCT02960438 still recruiting?

NCT02960438 is currently completed. Last updated 21 June 2021.

Are results published for NCT02960438?

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

Last reviewed 2021-06-21 · How we verify

NCT02960438

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

A Dose Response Study of E6011 in Participants With Rheumatoid Arthritis Inadequately Responding to Methotrexate

Completed Phase 2 Results posted Last updated 21 June 2021

What this trial tests

Phase 2 trial testing E6011 in Rheumatoid Arthritis in 273 participants. Completed in 17 September 2019.

Timeline

20 October 2016

Primary endpoint
28 February 2018

17 September 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	273
Start date	20 October 2016
Primary completion	28 February 2018
Estimated completion	17 September 2019
Sites	90 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.

Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) 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

Group	Value	95% CI
Treatment Phase: Placebo	37.0	24.16 – 49.92
Treatment Phase: E6011 100 mg	39.3	21.20 – 57.38
Treatment Phase: E6011 200 mg	48.1	34.82 – 61.47
Treatment Phase: E6011 400/200 mg	46.3	33.00 – 59.60

Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Secondary · Weeks 2, 4, 8, 16, 20, and 24

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.

Response at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	13.0	4.00 – 21.92
Treatment Phase: E6011 100 mg	14.3	1.32 – 27.25
Treatment Phase: E6011 200 mg	22.2	11.13 – 33.31
Treatment Phase: E6011 400/200 mg	20.4	9.63 – 31.11

Response at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	18.5	8.16 – 28.88
Treatment Phase: E6011 100 mg	28.6	11.84 – 45.30
Treatment Phase: E6011 200 mg	24.1	12.67 – 35.48
Treatment Phase: E6011 400/200 mg	31.5	19.09 – 43.87

Response at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	40.7	27.64 – 53.85
Treatment Phase: E6011 100 mg	35.7	17.97 – 53.46
Treatment Phase: E6011 200 mg	37.0	24.16 – 49.92
Treatment Phase: E6011 400/200 mg	46.3	33.00 – 59.60

Response at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	46.3	33.00 – 59.60
Treatment Phase: E6011 100 mg	46.4	27.96 – 64.90
Treatment Phase: E6011 200 mg	51.9	38.53 – 65.18
Treatment Phase: E6011 400/200 mg	53.7	40.40 – 67.00

Response at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	33.3	20.76 – 45.91
Treatment Phase: E6011 100 mg	50.0	31.48 – 68.52
Treatment Phase: E6011 200 mg	59.3	46.15 – 72.36
Treatment Phase: E6011 400/200 mg	55.6	42.30 – 68.81

Response at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	35.2	22.45 – 47.92
Treatment Phase: E6011 100 mg	39.3	21.20 – 57.38
Treatment Phase: E6011 200 mg	53.7	40.40 – 67.00
Treatment Phase: E6011 400/200 mg	57.4	44.22 – 70.60

Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Secondary · Weeks 2, 4, 8, 16, 20, and 24

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.

Response at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	1.9	0.00 – 5.45
Treatment Phase: E6011 100 mg	0.0	0.00 – 0.00
Treatment Phase: E6011 200 mg	7.4	0.42 – 14.39
Treatment Phase: E6011 400/200 mg	7.4	0.42 – 14.39

Response at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	0.0	0.00 – 0.00
Treatment Phase: E6011 100 mg	3.6	0.00 – 10.45
Treatment Phase: E6011 200 mg	3.7	0.00 – 8.74
Treatment Phase: E6011 400/200 mg	9.3	1.53 – 16.99

Response at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	7.4	0.42 – 14.39
Treatment Phase: E6011 100 mg	14.3	1.32 – 27.25
Treatment Phase: E6011 200 mg	3.7	0.00 – 8.74
Treatment Phase: E6011 400/200 mg	9.3	1.53 – 16.99

Response at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	14.8	5.34 – 24.29
Treatment Phase: E6011 100 mg	10.7	0.00 – 22.17
Treatment Phase: E6011 200 mg	25.9	14.24 – 37.61
Treatment Phase: E6011 400/200 mg	18.5	8.16 – 28.88

Response at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	14.8	5.34 – 24.29
Treatment Phase: E6011 100 mg	17.9	3.67 – 32.04
Treatment Phase: E6011 200 mg	20.4	9.63 – 31.11
Treatment Phase: E6011 400/200 mg	22.2	11.13 – 33.31

Response at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	14.8	5.34 – 24.29
Treatment Phase: E6011 100 mg	10.7	0.00 – 22.17
Treatment Phase: E6011 200 mg	31.5	19.09 – 43.87
Treatment Phase: E6011 400/200 mg	25.9	14.24 – 37.61

Response at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	16.7	6.73 – 26.61
Treatment Phase: E6011 100 mg	17.9	3.67 – 32.04
Treatment Phase: E6011 200 mg	25.9	14.24 – 37.61
Treatment Phase: E6011 400/200 mg	27.8	15.83 – 39.72

Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Secondary · Weeks 2, 4, 8, 16, 20, and 24

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.

Response at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	0.0	0.00 – 0.00
Treatment Phase: E6011 100 mg	0.0	0.00 – 0.00
Treatment Phase: E6011 200 mg	1.9	0.00 – 5.45
Treatment Phase: E6011 400/200 mg	0.0	0.00 – 0.00

Response at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	0.0	0.00 – 0.00
Treatment Phase: E6011 100 mg	0.0	0.00 – 0.00
Treatment Phase: E6011 200 mg	0.0	0.00 – 0.00
Treatment Phase: E6011 400/200 mg	1.9	0.00 – 5.45

Response at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	1.9	0.00 – 5.45
Treatment Phase: E6011 100 mg	0.0	0.00 – 0.00
Treatment Phase: E6011 200 mg	0.0	0.00 – 0.00
Treatment Phase: E6011 400/200 mg	5.6	0.00 – 11.67

Response at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	3.7	0.00 – 8.74
Treatment Phase: E6011 100 mg	3.6	0.00 – 10.45
Treatment Phase: E6011 200 mg	9.3	1.53 – 16.99
Treatment Phase: E6011 400/200 mg	7.4	0.42 – 14.39

Response at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	5.6	0.00 – 11.67
Treatment Phase: E6011 100 mg	7.1	0.00 – 16.68
Treatment Phase: E6011 200 mg	3.7	0.00 – 8.74
Treatment Phase: E6011 400/200 mg	13.0	4.00 – 21.92

Response at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	5.6	0.00 – 11.67
Treatment Phase: E6011 100 mg	7.1	0.00 – 16.68
Treatment Phase: E6011 200 mg	11.1	2.73 – 19.49
Treatment Phase: E6011 400/200 mg	14.8	5.34 – 24.29

Response at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	5.6	0.00 – 11.67
Treatment Phase: E6011 100 mg	14.3	1.32 – 27.25
Treatment Phase: E6011 200 mg	11.1	2.73 – 19.49
Treatment Phase: E6011 400/200 mg	13.0	4.00 – 21.92

Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Secondary · 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, 72, 76, 80, and 84

A total of 68 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Ph

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	13.7	± 6.81
Treatment Phase: E6011 100 mg	14.1	± 7.24
Treatment Phase: E6011 200 mg	16.3	± 7.15
Treatment Phase: E6011 400/200 mg	16.6	± 9.61
Extension Phase: Placebo	13.6	± 6.72
Extension Phase: E6011 100 mg	14.3	± 7.49
Extension Phase: E6011 200 mg	15.7	± 6.70
Extension Phase: E6011 400/200 mg	16.6	± 9.07

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	-2.9	± 5.63
Treatment Phase: E6011 100 mg	-2.7	± 5.05
Treatment Phase: E6011 200 mg	-3.6	± 5.99
Treatment Phase: E6011 400/200 mg	-3.9	± 6.00
Extension Phase: Placebo	-3.2	± 4.88
Extension Phase: E6011 100 mg	-2.5	± 5.01
Extension Phase: E6011 200 mg	-3.4	± 5.99
Extension Phase: E6011 400/200 mg	-4.5	± 6.27

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	-2.9	± 6.04
Treatment Phase: E6011 100 mg	-2.9	± 4.47
Treatment Phase: E6011 200 mg	-4.5	± 5.34
Treatment Phase: E6011 400/200 mg	-5.8	± 7.68
Extension Phase: Placebo	-3.0	± 5.63
Extension Phase: E6011 100 mg	-2.8	± 4.44
Extension Phase: E6011 200 mg	-4.5	± 5.29
Extension Phase: E6011 400/200 mg	-6.7	± 7.62

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	-3.9	± 7.00
Treatment Phase: E6011 100 mg	-4.6	± 5.55
Treatment Phase: E6011 200 mg	-5.7	± 6.14
Treatment Phase: E6011 400/200 mg	-6.7	± 9.30
Extension Phase: Placebo	-4.7	± 6.12
Extension Phase: E6011 100 mg	-4.6	± 5.36
Extension Phase: E6011 200 mg	-5.7	± 5.98
Extension Phase: E6011 400/200 mg	-7.6	± 9.55

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	-4.2	± 7.40
Treatment Phase: E6011 100 mg	-5.2	± 6.83
Treatment Phase: E6011 200 mg	-7.1	± 7.42
Treatment Phase: E6011 400/200 mg	-7.9	± 9.77
Extension Phase: Placebo	-5.0	± 6.54
Extension Phase: E6011 100 mg	-5.3	± 6.83
Extension Phase: E6011 200 mg	-7.3	± 7.18
Extension Phase: E6011 400/200 mg	-8.9	± 10.10

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	-5.3	± 7.51
Treatment Phase: E6011 100 mg	-6.4	± 7.34
Treatment Phase: E6011 200 mg	-8.4	± 6.53
Treatment Phase: E6011 400/200 mg	-7.9	± 10.33
Extension Phase: Placebo	-6.3	± 6.53
Extension Phase: E6011 100 mg	-6.6	± 7.36
Extension Phase: E6011 200 mg	-8.6	± 6.20
Extension Phase: E6011 400/200 mg	-9.3	± 9.95

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	-5.6	± 8.50
Treatment Phase: E6011 100 mg	-6.9	± 7.33
Treatment Phase: E6011 200 mg	-7.6	± 7.72
Treatment Phase: E6011 400/200 mg	-8.5	± 9.68
Extension Phase: Placebo	-6.8	± 7.70
Extension Phase: E6011 100 mg	-7.2	± 7.31
Extension Phase: E6011 200 mg	-7.8	± 7.59
Extension Phase: E6011 400/200 mg	-10.0	± 9.06

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	-5.6	± 7.97
Treatment Phase: E6011 100 mg	-6.9	± 7.55
Treatment Phase: E6011 200 mg	-8.6	± 7.38
Treatment Phase: E6011 400/200 mg	-8.7	± 9.93
Extension Phase: Placebo	-6.8	± 7.02
Extension Phase: E6011 100 mg	-7.2	± 7.55
Extension Phase: E6011 200 mg	-8.9	± 7.13
Extension Phase: E6011 400/200 mg	-10.4	± 9.36

Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Secondary · 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, 72, 76, 80, and 84

A total of 66 joints (minus 2 hip joints from evaluated tender 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	12.7	± 6.81
Treatment Phase: E6011 100 mg	11.3	± 5.27
Treatment Phase: E6011 200 mg	12.4	± 4.89
Treatment Phase: E6011 400/200 mg	13.5	± 6.41
Extension Phase: Placebo	12.7	± 6.48
Extension Phase: E6011 100 mg	11.5	± 5.38
Extension Phase: E6011 200 mg	12.1	± 4.63
Extension Phase: E6011 400/200 mg	13.8	± 6.18

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	-2.2	± 4.70
Treatment Phase: E6011 100 mg	-2.8	± 3.33
Treatment Phase: E6011 200 mg	-2.9	± 4.18
Treatment Phase: E6011 400/200 mg	-3.4	± 5.25
Extension Phase: Placebo	-2.9	± 4.21
Extension Phase: E6011 100 mg	-2.9	± 3.46
Extension Phase: E6011 200 mg	-3.0	± 3.84
Extension Phase: E6011 400/200 mg	-3.7	± 5.17

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	-3.0	± 5.36
Treatment Phase: E6011 100 mg	-3.7	± 3.42
Treatment Phase: E6011 200 mg	-3.3	± 4.66
Treatment Phase: E6011 400/200 mg	-5.0	± 4.95
Extension Phase: Placebo	-3.8	± 3.94
Extension Phase: E6011 100 mg	-3.8	± 3.51
Extension Phase: E6011 200 mg	-3.5	± 4.03
Extension Phase: E6011 400/200 mg	-5.5	± 5.01

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	-4.1	± 7.33
Treatment Phase: E6011 100 mg	-4.7	± 4.16
Treatment Phase: E6011 200 mg	-3.8	± 5.82
Treatment Phase: E6011 400/200 mg	-6.0	± 5.81
Extension Phase: Placebo	-5.7	± 4.70
Extension Phase: E6011 100 mg	-4.7	± 4.32
Extension Phase: E6011 200 mg	-3.8	± 5.42
Extension Phase: E6011 400/200 mg	-6.7	± 5.74

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	-4.2	± 7.05
Treatment Phase: E6011 100 mg	-5.1	± 4.91
Treatment Phase: E6011 200 mg	-4.9	± 5.39
Treatment Phase: E6011 400/200 mg	-5.7	± 6.41
Extension Phase: Placebo	-5.9	± 4.11
Extension Phase: E6011 100 mg	-5.2	± 5.08
Extension Phase: E6011 200 mg	-5.2	± 4.93
Extension Phase: E6011 400/200 mg	-6.4	± 6.34

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	-4.3	± 7.38
Treatment Phase: E6011 100 mg	-6.1	± 4.32
Treatment Phase: E6011 200 mg	-5.2	± 5.30
Treatment Phase: E6011 400/200 mg	-6.6	± 6.60
Extension Phase: Placebo	-6.0	± 4.65
Extension Phase: E6011 100 mg	-6.3	± 4.43
Extension Phase: E6011 200 mg	-5.5	± 4.81
Extension Phase: E6011 400/200 mg	-8.0	± 5.68

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	-5.1	± 8.73
Treatment Phase: E6011 100 mg	-6.4	± 4.65
Treatment Phase: E6011 200 mg	-5.6	± 5.71
Treatment Phase: E6011 400/200 mg	-6.4	± 7.26
Extension Phase: Placebo	-7.0	± 6.50
Extension Phase: E6011 100 mg	-6.6	± 4.78
Extension Phase: E6011 200 mg	-5.8	± 5.28
Extension Phase: E6011 400/200 mg	-7.7	± 6.61

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	-5.1	± 8.32
Treatment Phase: E6011 100 mg	-6.3	± 4.28
Treatment Phase: E6011 200 mg	-5.9	± 6.38
Treatment Phase: E6011 400/200 mg	-6.2	± 6.65
Extension Phase: Placebo	-7.0	± 5.86
Extension Phase: E6011 100 mg	-6.5	± 4.38
Extension Phase: E6011 200 mg	-6.2	± 5.93
Extension Phase: E6011 400/200 mg	-7.6	± 5.74

Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Secondary · 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, 72, 76, 80, and 84

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. 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave conse

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	53.6	± 23.03
Treatment Phase: E6011 100 mg	47.9	± 26.37
Treatment Phase: E6011 200 mg	46.6	± 23.03
Treatment Phase: E6011 400/200 mg	52.9	± 24.38
Extension Phase: Placebo	54.2	± 21.89
Extension Phase: E6011 100 mg	46.6	± 26.94
Extension Phase: E6011 200 mg	46.7	± 22.95
Extension Phase: E6011 400/200 mg	49.6	± 24.25

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	-4.0	± 17.96
Treatment Phase: E6011 100 mg	-4.5	± 12.64
Treatment Phase: E6011 200 mg	-6.2	± 17.22
Treatment Phase: E6011 400/200 mg	-5.9	± 16.91
Extension Phase: Placebo	-5.2	± 18.88
Extension Phase: E6011 100 mg	-4.4	± 13.08
Extension Phase: E6011 200 mg	-6.4	± 17.81
Extension Phase: E6011 400/200 mg	-5.1	± 17.00

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	-5.8	± 22.47
Treatment Phase: E6011 100 mg	-6.4	± 20.68
Treatment Phase: E6011 200 mg	-4.1	± 18.36
Treatment Phase: E6011 400/200 mg	-9.0	± 18.93
Extension Phase: Placebo	-9.0	± 21.34
Extension Phase: E6011 100 mg	-6.6	± 21.47
Extension Phase: E6011 200 mg	-4.4	± 18.77
Extension Phase: E6011 400/200 mg	-8.3	± 19.19

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	-7.8	± 20.76
Treatment Phase: E6011 100 mg	-4.9	± 19.96
Treatment Phase: E6011 200 mg	-10.0	± 18.29
Treatment Phase: E6011 400/200 mg	-16.6	± 22.58
Extension Phase: Placebo	-10.5	± 18.73
Extension Phase: E6011 100 mg	-5.7	± 20.51
Extension Phase: E6011 200 mg	-11.0	± 18.45
Extension Phase: E6011 400/200 mg	-17.0	± 23.50

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	-7.5	± 26.09
Treatment Phase: E6011 100 mg	-12.2	± 18.19
Treatment Phase: E6011 200 mg	-12.9	± 21.24
Treatment Phase: E6011 400/200 mg	-13.7	± 25.24
Extension Phase: Placebo	-11.0	± 25.10
Extension Phase: E6011 100 mg	-12.8	± 18.75
Extension Phase: E6011 200 mg	-14.6	± 20.72
Extension Phase: E6011 400/200 mg	-15.2	± 26.57

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	-10.8	± 27.25
Treatment Phase: E6011 100 mg	-11.4	± 19.69
Treatment Phase: E6011 200 mg	-13.6	± 20.87
Treatment Phase: E6011 400/200 mg	-15.1	± 25.78
Extension Phase: Placebo	-14.1	± 26.26
Extension Phase: E6011 100 mg	-11.7	± 20.42
Extension Phase: E6011 200 mg	-14.8	± 20.91
Extension Phase: E6011 400/200 mg	-17.8	± 26.62

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	-9.1	± 29.43
Treatment Phase: E6011 100 mg	-13.5	± 19.33
Treatment Phase: E6011 200 mg	-15.0	± 21.08
Treatment Phase: E6011 400/200 mg	-16.6	± 26.04
Extension Phase: Placebo	-12.9	± 28.35
Extension Phase: E6011 100 mg	-14.4	± 19.75
Extension Phase: E6011 200 mg	-16.6	± 20.67
Extension Phase: E6011 400/200 mg	-19.3	± 26.67

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	-9.4	± 28.49
Treatment Phase: E6011 100 mg	-13.9	± 21.59
Treatment Phase: E6011 200 mg	-14.4	± 20.85
Treatment Phase: E6011 400/200 mg	-18.5	± 24.29
Extension Phase: Placebo	-13.2	± 27.17
Extension Phase: E6011 100 mg	-14.8	± 22.11
Extension Phase: E6011 200 mg	-16.0	± 20.47
Extension Phase: E6011 400/200 mg	-21.6	± 24.35

Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Secondary · 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, 72, 76, 80, and 84

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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	53.1	± 25.74
Treatment Phase: E6011 100 mg	50.1	± 25.04
Treatment Phase: E6011 200 mg	49.0	± 22.37
Treatment Phase: E6011 400/200 mg	54.5	± 23.97
Extension Phase: Placebo	53.4	± 25.30
Extension Phase: E6011 100 mg	49.2	± 25.77
Extension Phase: E6011 200 mg	49.2	± 22.19
Extension Phase: E6011 400/200 mg	51.3	± 23.89

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	-2.9	± 20.03
Treatment Phase: E6011 100 mg	-4.2	± 14.32
Treatment Phase: E6011 200 mg	-8.3	± 17.32
Treatment Phase: E6011 400/200 mg	-6.4	± 16.40
Extension Phase: Placebo	-3.8	± 21.28
Extension Phase: E6011 100 mg	-4.5	± 14.70
Extension Phase: E6011 200 mg	-8.5	± 17.84
Extension Phase: E6011 400/200 mg	-5.5	± 16.45

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	-6.4	± 24.49
Treatment Phase: E6011 100 mg	-6.6	± 17.03
Treatment Phase: E6011 200 mg	-7.2	± 16.29
Treatment Phase: E6011 400/200 mg	-9.8	± 19.73
Extension Phase: Placebo	-9.4	± 23.96
Extension Phase: E6011 100 mg	-7.0	± 17.50
Extension Phase: E6011 200 mg	-7.6	± 16.64
Extension Phase: E6011 400/200 mg	-9.5	± 20.26

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	-5.5	± 23.48
Treatment Phase: E6011 100 mg	-7.3	± 18.62
Treatment Phase: E6011 200 mg	-11.6	± 18.67
Treatment Phase: E6011 400/200 mg	-18.1	± 23.66
Extension Phase: Placebo	-7.5	± 22.61
Extension Phase: E6011 100 mg	-8.5	± 18.82
Extension Phase: E6011 200 mg	-12.8	± 18.80
Extension Phase: E6011 400/200 mg	-18.8	± 24.76

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	-7.3	± 27.83
Treatment Phase: E6011 100 mg	-14.6	± 18.22
Treatment Phase: E6011 200 mg	-15.2	± 18.50
Treatment Phase: E6011 400/200 mg	-15.1	± 27.23
Extension Phase: Placebo	-10.0	± 27.59
Extension Phase: E6011 100 mg	-15.8	± 18.36
Extension Phase: E6011 200 mg	-17.0	± 17.62
Extension Phase: E6011 400/200 mg	-17.3	± 28.74

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	-11.6	± 27.40
Treatment Phase: E6011 100 mg	-14.0	± 20.19
Treatment Phase: E6011 200 mg	-16.1	± 20.49
Treatment Phase: E6011 400/200 mg	-16.6	± 27.22
Extension Phase: Placebo	-14.7	± 26.47
Extension Phase: E6011 100 mg	-15.3	± 20.31
Extension Phase: E6011 200 mg	-17.4	± 20.46
Extension Phase: E6011 400/200 mg	-19.3	± 28.40

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	-10.0	± 30.67
Treatment Phase: E6011 100 mg	-15.3	± 19.24
Treatment Phase: E6011 200 mg	-17.4	± 21.43
Treatment Phase: E6011 400/200 mg	-17.8	± 28.14
Extension Phase: Placebo	-13.6	± 29.69
Extension Phase: E6011 100 mg	-17.0	± 18.89
Extension Phase: E6011 200 mg	-19.2	± 21.03
Extension Phase: E6011 400/200 mg	-20.7	± 29.30

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	-8.8	± 30.97
Treatment Phase: E6011 100 mg	-15.3	± 23.29
Treatment Phase: E6011 200 mg	-17.8	± 20.27
Treatment Phase: E6011 400/200 mg	-20.4	± 24.90
Extension Phase: Placebo	-12.3	± 30.20
Extension Phase: E6011 100 mg	-17.0	± 23.30
Extension Phase: E6011 200 mg	-19.6	± 19.72
Extension Phase: E6011 400/200 mg	-23.8	± 25.11

Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Secondary · 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, 72, 76, 80, and 84

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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	54.3	± 19.07
Treatment Phase: E6011 100 mg	53.1	± 21.88
Treatment Phase: E6011 200 mg	55.2	± 17.27
Treatment Phase: E6011 400/200 mg	54.2	± 22.02
Extension Phase: Placebo	53.7	± 19.17
Extension Phase: E6011 100 mg	52.0	± 22.20
Extension Phase: E6011 200 mg	54.2	± 17.30
Extension Phase: E6011 400/200 mg	53.9	± 21.28

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	-10.1	± 15.95
Treatment Phase: E6011 100 mg	-9.5	± 16.32
Treatment Phase: E6011 200 mg	-11.1	± 15.59
Treatment Phase: E6011 400/200 mg	-7.9	± 16.61
Extension Phase: Placebo	-10.4	± 14.73
Extension Phase: E6011 100 mg	-7.3	± 14.59
Extension Phase: E6011 200 mg	-10.3	± 15.78
Extension Phase: E6011 400/200 mg	-8.1	± 17.63

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	-8.4	± 16.83
Treatment Phase: E6011 100 mg	-7.6	± 14.11
Treatment Phase: E6011 200 mg	-15.2	± 16.36
Treatment Phase: E6011 400/200 mg	-13.2	± 20.76
Extension Phase: Placebo	-9.9	± 15.99
Extension Phase: E6011 100 mg	-6.7	± 13.23
Extension Phase: E6011 200 mg	-15.0	± 16.68
Extension Phase: E6011 400/200 mg	-13.8	± 21.74

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	-13.6	± 21.08
Treatment Phase: E6011 100 mg	-11.3	± 16.87
Treatment Phase: E6011 200 mg	-16.6	± 20.75
Treatment Phase: E6011 400/200 mg	-16.1	± 21.51
Extension Phase: Placebo	-15.5	± 17.70
Extension Phase: E6011 100 mg	-9.3	± 15.25
Extension Phase: E6011 200 mg	-16.7	± 21.00
Extension Phase: E6011 400/200 mg	-19.0	± 21.63

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	-14.9	± 24.14
Treatment Phase: E6011 100 mg	-16.9	± 24.74
Treatment Phase: E6011 200 mg	-21.6	± 18.54
Treatment Phase: E6011 400/200 mg	-18.1	± 26.27
Extension Phase: Placebo	-17.1	± 21.36
Extension Phase: E6011 100 mg	-16.8	± 25.04
Extension Phase: E6011 200 mg	-22.3	± 17.53
Extension Phase: E6011 400/200 mg	-19.5	± 26.63

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	-16.1	± 23.49
Treatment Phase: E6011 100 mg	-19.3	± 20.88
Treatment Phase: E6011 200 mg	-23.1	± 20.21
Treatment Phase: E6011 400/200 mg	-19.3	± 25.83
Extension Phase: Placebo	-19.1	± 21.49
Extension Phase: E6011 100 mg	-19.3	± 20.91
Extension Phase: E6011 200 mg	-23.6	± 20.00
Extension Phase: E6011 400/200 mg	-23.7	± 23.80

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	-15.3	± 25.97
Treatment Phase: E6011 100 mg	-20.0	± 21.27
Treatment Phase: E6011 200 mg	-22.7	± 20.32
Treatment Phase: E6011 400/200 mg	-18.9	± 28.39
Extension Phase: Placebo	-18.8	± 24.20
Extension Phase: E6011 100 mg	-20.9	± 21.65
Extension Phase: E6011 200 mg	-23.3	± 19.81
Extension Phase: E6011 400/200 mg	-23.1	± 27.08

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	-15.5	± 26.23
Treatment Phase: E6011 100 mg	-17.8	± 24.33
Treatment Phase: E6011 200 mg	-24.6	± 21.38
Treatment Phase: E6011 400/200 mg	-20.8	± 27.39
Extension Phase: Placebo	-19.0	± 24.49
Extension Phase: E6011 100 mg	-18.4	± 24.96
Extension Phase: E6011 200 mg	-25.4	± 20.91
Extension Phase: E6011 400/200 mg	-25.7	± 25.19

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Secondary · 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, 72, 76, 80, and 84

The degree of disability was self-evaluated by the participant using the HAQ-DI. The assessment was made based on the activities capable without any aids or devices. The 20-question instrument assessed the degree of difficulty a 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 a task in that area. Overall score was computed as the sum of domain scores and divided by the numbe

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	0.77	± 0.526
Treatment Phase: E6011 100 mg	0.73	± 0.527
Treatment Phase: E6011 200 mg	0.75	± 0.602
Treatment Phase: E6011 400/200 mg	0.80	± 0.611
Extension Phase: Placebo	0.75	± 0.519
Extension Phase: E6011 100 mg	0.72	± 0.541
Extension Phase: E6011 200 mg	0.74	± 0.618
Extension Phase: E6011 400/200 mg	0.71	± 0.543

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	0.00	± 0.281
Treatment Phase: E6011 100 mg	-0.01	± 0.236
Treatment Phase: E6011 200 mg	-0.06	± 0.295
Treatment Phase: E6011 400/200 mg	-0.06	± 0.301
Extension Phase: Placebo	-0.03	± 0.223
Extension Phase: E6011 100 mg	0.00	± 0.240
Extension Phase: E6011 200 mg	-0.05	± 0.297
Extension Phase: E6011 400/200 mg	-0.05	± 0.306

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	0.02	± 0.352
Treatment Phase: E6011 100 mg	0.01	± 0.277
Treatment Phase: E6011 200 mg	-0.07	± 0.299
Treatment Phase: E6011 400/200 mg	-0.10	± 0.303
Extension Phase: Placebo	-0.02	± 0.265
Extension Phase: E6011 100 mg	0.03	± 0.281
Extension Phase: E6011 200 mg	-0.06	± 0.301
Extension Phase: E6011 400/200 mg	-0.12	± 0.304

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	0.00	± 0.432
Treatment Phase: E6011 100 mg	-0.03	± 0.298
Treatment Phase: E6011 200 mg	-0.10	± 0.323
Treatment Phase: E6011 400/200 mg	-0.12	± 0.329
Extension Phase: Placebo	-0.03	± 0.379
Extension Phase: E6011 100 mg	-0.03	± 0.296
Extension Phase: E6011 200 mg	-0.08	± 0.319
Extension Phase: E6011 400/200 mg	-0.13	± 0.350

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	0.01	± 0.493
Treatment Phase: E6011 100 mg	-0.06	± 0.356
Treatment Phase: E6011 200 mg	-0.13	± 0.321
Treatment Phase: E6011 400/200 mg	-0.14	± 0.402
Extension Phase: Placebo	-0.02	± 0.463
Extension Phase: E6011 100 mg	-0.04	± 0.351
Extension Phase: E6011 200 mg	-0.11	± 0.321
Extension Phase: E6011 400/200 mg	-0.16	± 0.422

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	-0.03	± 0.469
Treatment Phase: E6011 100 mg	-0.08	± 0.330
Treatment Phase: E6011 200 mg	-0.19	± 0.330
Treatment Phase: E6011 400/200 mg	-0.13	± 0.411
Extension Phase: Placebo	-0.06	± 0.434
Extension Phase: E6011 100 mg	-0.06	± 0.315
Extension Phase: E6011 200 mg	-0.18	± 0.332
Extension Phase: E6011 400/200 mg	-0.15	± 0.433

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	0.02	± 0.519
Treatment Phase: E6011 100 mg	-0.10	± 0.285
Treatment Phase: E6011 200 mg	-0.17	± 0.335
Treatment Phase: E6011 400/200 mg	-0.14	± 0.435
Extension Phase: Placebo	-0.03	± 0.485
Extension Phase: E6011 100 mg	-0.09	± 0.285
Extension Phase: E6011 200 mg	-0.17	± 0.337
Extension Phase: E6011 400/200 mg	-0.16	± 0.461

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	-0.02	± 0.494
Treatment Phase: E6011 100 mg	-0.09	± 0.300
Treatment Phase: E6011 200 mg	-0.17	± 0.337
Treatment Phase: E6011 400/200 mg	-0.17	± 0.446
Extension Phase: Placebo	-0.07	± 0.450
Extension Phase: E6011 100 mg	-0.08	± 0.300
Extension Phase: E6011 200 mg	-0.16	± 0.339
Extension Phase: E6011 400/200 mg	-0.20	± 0.470

Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Secondary · 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, 72, 76, 80, and 84

CRP of each participants was measured as a part of blood biochemical tests. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	1.50	± 1.633
Treatment Phase: E6011 100 mg	1.44	± 1.868
Treatment Phase: E6011 200 mg	1.08	± 0.840
Treatment Phase: E6011 400/200 mg	1.24	± 1.634
Extension Phase: Placebo	1.42	± 1.682
Extension Phase: E6011 100 mg	1.41	± 1.901
Extension Phase: E6011 200 mg	1.04	± 0.843
Extension Phase: E6011 400/200 mg	1.07	± 1.291

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	-0.09	± 0.909
Treatment Phase: E6011 100 mg	-0.28	± 1.148
Treatment Phase: E6011 200 mg	0.08	± 0.707
Treatment Phase: E6011 400/200 mg	0.07	± 0.777
Extension Phase: Placebo	-0.16	± 0.930
Extension Phase: E6011 100 mg	-0.32	± 1.176
Extension Phase: E6011 200 mg	0.08	± 0.715
Extension Phase: E6011 400/200 mg	0.12	± 0.769

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	0.06	± 1.235
Treatment Phase: E6011 100 mg	0.20	± 1.279
Treatment Phase: E6011 200 mg	0.04	± 0.707
Treatment Phase: E6011 400/200 mg	0.33	± 1.383
Extension Phase: Placebo	-0.14	± 1.134
Extension Phase: E6011 100 mg	0.15	± 1.268
Extension Phase: E6011 200 mg	0.03	± 0.694
Extension Phase: E6011 400/200 mg	0.28	± 1.443

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	0.21	± 1.192
Treatment Phase: E6011 100 mg	0.12	± 1.750
Treatment Phase: E6011 200 mg	0.29	± 1.407
Treatment Phase: E6011 400/200 mg	-0.03	± 1.343
Extension Phase: Placebo	0.04	± 1.103
Extension Phase: E6011 100 mg	0.08	± 1.787
Extension Phase: E6011 200 mg	0.28	± 1.452
Extension Phase: E6011 400/200 mg	-0.15	± 1.392

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	0.15	± 1.503
Treatment Phase: E6011 100 mg	-0.23	± 1.429
Treatment Phase: E6011 200 mg	-0.06	± 1.263
Treatment Phase: E6011 400/200 mg	-0.05	± 1.403
Extension Phase: Placebo	0.01	± 1.485
Extension Phase: E6011 100 mg	-0.26	± 1.481
Extension Phase: E6011 200 mg	-0.07	± 1.309
Extension Phase: E6011 400/200 mg	-0.24	± 1.314

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	0.17	± 1.429
Treatment Phase: E6011 100 mg	-0.26	± 1.626
Treatment Phase: E6011 200 mg	-0.11	± 1.214
Treatment Phase: E6011 400/200 mg	0.09	± 1.737
Extension Phase: Placebo	0.00	± 1.412
Extension Phase: E6011 100 mg	-0.29	± 1.684
Extension Phase: E6011 200 mg	-0.10	± 1.249
Extension Phase: E6011 400/200 mg	-0.08	± 1.713

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	0.24	± 1.686
Treatment Phase: E6011 100 mg	-0.17	± 1.683
Treatment Phase: E6011 200 mg	-0.18	± 1.071
Treatment Phase: E6011 400/200 mg	0.01	± 1.332
Extension Phase: Placebo	0.00	± 1.652
Extension Phase: E6011 100 mg	-0.25	± 1.712
Extension Phase: E6011 200 mg	-0.23	± 1.060
Extension Phase: E6011 400/200 mg	-0.14	± 1.154

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	0.39	± 2.063
Treatment Phase: E6011 100 mg	-0.26	± 1.887
Treatment Phase: E6011 200 mg	0.01	± 1.155
Treatment Phase: E6011 400/200 mg	0.38	± 2.220
Extension Phase: Placebo	0.18	± 2.106
Extension Phase: E6011 100 mg	-0.35	± 1.924
Extension Phase: E6011 200 mg	-0.03	± 1.161
Extension Phase: E6011 400/200 mg	0.30	± 2.269

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Secondary · 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, 72, 76, 80,and 84

ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Baseline

Group	Value	95% CI
Treatment Phase: Placebo	41.6	± 26.37
Treatment Phase: E6011 100 mg	37.9	± 16.62
Treatment Phase: E6011 200 mg	40.8	± 20.06
Treatment Phase: E6011 400/200 mg	40.1	± 20.45
Extension Phase: Placebo	39.6	± 26.47
Extension Phase: E6011 100 mg	37.6	± 17.21
Extension Phase: E6011 200 mg	40.0	± 19.67
Extension Phase: E6011 400/200 mg	38.3	± 16.91

Change at Week 2

Group	Value	95% CI
Treatment Phase: Placebo	-3.8	± 10.40
Treatment Phase: E6011 100 mg	1.0	± 8.25
Treatment Phase: E6011 200 mg	-1.9	± 7.53
Treatment Phase: E6011 400/200 mg	0.7	± 10.38
Extension Phase: Placebo	-4.1	± 10.49
Extension Phase: E6011 100 mg	1.7	± 8.00
Extension Phase: E6011 200 mg	-2.1	± 7.70
Extension Phase: E6011 400/200 mg	0.4	± 10.92

Change at Week 4

Group	Value	95% CI
Treatment Phase: Placebo	-2.3	± 14.51
Treatment Phase: E6011 100 mg	1.3	± 11.79
Treatment Phase: E6011 200 mg	-2.6	± 7.42
Treatment Phase: E6011 400/200 mg	-1.1	± 13.38
Extension Phase: Placebo	-3.4	± 14.07
Extension Phase: E6011 100 mg	1.3	± 12.22
Extension Phase: E6011 200 mg	-2.8	± 7.62
Extension Phase: E6011 400/200 mg	-2.2	± 13.49

Change at Week 8

Group	Value	95% CI
Treatment Phase: Placebo	0.2	± 17.72
Treatment Phase: E6011 100 mg	-0.3	± 11.62
Treatment Phase: E6011 200 mg	-1.8	± 14.43
Treatment Phase: E6011 400/200 mg	-3.7	± 15.09
Extension Phase: Placebo	-1.5	± 16.90
Extension Phase: E6011 100 mg	-0.5	± 11.55
Extension Phase: E6011 200 mg	-2.7	± 14.19
Extension Phase: E6011 400/200 mg	-5.3	± 15.29

Change at Week 12

Group	Value	95% CI
Treatment Phase: Placebo	-0.3	± 16.46
Treatment Phase: E6011 100 mg	-2.9	± 15.53
Treatment Phase: E6011 200 mg	-3.8	± 18.39
Treatment Phase: E6011 400/200 mg	-3.5	± 17.83
Extension Phase: Placebo	-1.5	± 15.28
Extension Phase: E6011 100 mg	-3.4	± 16.00
Extension Phase: E6011 200 mg	-4.7	± 18.38
Extension Phase: E6011 400/200 mg	-5.7	± 17.77

Change at Week 16

Group	Value	95% CI
Treatment Phase: Placebo	-1.9	± 15.78
Treatment Phase: E6011 100 mg	-3.3	± 18.53
Treatment Phase: E6011 200 mg	-5.5	± 20.68
Treatment Phase: E6011 400/200 mg	-2.2	± 19.92
Extension Phase: Placebo	-3.6	± 14.47
Extension Phase: E6011 100 mg	-3.8	± 19.14
Extension Phase: E6011 200 mg	-6.0	± 21.05
Extension Phase: E6011 400/200 mg	-4.7	± 20.03

Change at Week 20

Group	Value	95% CI
Treatment Phase: Placebo	-0.6	± 22.08
Treatment Phase: E6011 100 mg	-1.3	± 18.75
Treatment Phase: E6011 200 mg	-6.6	± 20.32
Treatment Phase: E6011 400/200 mg	-4.0	± 19.17
Extension Phase: Placebo	-2.3	± 21.23
Extension Phase: E6011 100 mg	-2.3	± 19.00
Extension Phase: E6011 200 mg	-8.0	± 19.80
Extension Phase: E6011 400/200 mg	-6.8	± 18.86

Change at Week 24

Group	Value	95% CI
Treatment Phase: Placebo	-0.1	± 23.16
Treatment Phase: E6011 100 mg	0.6	± 20.14
Treatment Phase: E6011 200 mg	-4.0	± 21.67
Treatment Phase: E6011 400/200 mg	-2.9	± 20.41
Extension Phase: Placebo	-1.8	± 22.56
Extension Phase: E6011 100 mg	-0.3	± 20.57
Extension Phase: E6011 200 mg	-5.2	± 21.47
Extension Phase: E6011 400/200 mg	-5.4	± 20.52

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.

Treatment Phase: Placebo

Serious: 2/54 (4%)

Deaths: 0/54

Treatment Phase: E6011 100 mg

Serious: 1/28 (4%)

Deaths: 0/28

Treatment Phase: E6011 200 mg

Serious: 2/54 (4%)

Deaths: 0/54

Treatment Phase: E6011 400/200 mg

Serious: 3/54 (6%)

Deaths: 0/54

Extension Phase: Placebo

Serious: 4/47 (9%)

Deaths: 0/47

Extension Phase: E6011 100 mg

Serious: 1/26 (4%)

Deaths: 0/26

Extension Phase: E6011 200 mg

Serious: 7/50 (14%)

Deaths: 0/50

Extension Phase: E6011 400/200 mg

Serious: 6/46 (13%)

Deaths: 0/46

Serious adverse events (24 terms)

Reaction	System	Treatment Phase: Placebo	Treatment Phase: E6011 100…	Treatment Phase: E6011 200…	Treatment Phase: E6011 400…	Extension Phase: Placebo	Extension Phase: E6011 100…	Extension Phase: E6011 200…	Extension Phase: E6011 400…
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—	—	—	—	—
Pneumocystis jirovecii pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Ulna fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Facial paralysis	Nervous system disorders	—	—	—	—	—	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vascular stent restenosis	General disorders	—	—	—	—	—	—	—	—
Bronchitis bacterial	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia bacterial	Infections and infestations	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Extremity contracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—

Other adverse events (293 terms — click to expand)

Reaction	System	Treatment Phase: Placebo	Treatment Phase: E6011 100…	Treatment Phase: E6011 200…	Treatment Phase: E6011 400…	Extension Phase: Placebo	Extension Phase: E6011 100…	Extension Phase: E6011 200…	Extension Phase: E6011 400…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Hyperkeratosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—	—
Angular cheilitis	Infections and infestations	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Large intestine polyp	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Tooth fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Vertigo positional	Ear and labyrinth disorders	—	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Anaemia, Diverticulitis, Pneumocystis jirovecii pneumonia, Pyelonephritis acute, Sepsis, Radius fracture, Ulna fracture, Facial paralysis.

Data from ClinicalTrials.gov NCT02960438 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 methotrexate.

Publications & conference data

3 peer-reviewed publications 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
Efficacy and Safety of E6011, an Anti-Fractalkine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis With Inadequate Response to Methotrexate: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Study.
Tanaka Y, Takeuchi T, Yamanaka H, Nanki T, et al · · 2021 · cited 20× · PMID 33038062 · DOI 10.1002/art.41555
Cytotoxic CD4<sup>+</sup> T cells: origin, biological functions, diseases and therapeutic targets.
Lai L, Ran S, Li Y, Cui J, et al · · 2026 · PMID 41803090 · DOI 10.1038/s41392-025-02533-z

Verify or expand the search:

Other trials of E6011

Trials testing the same drug.

NCT03733314 — A Study of E6011 in Participants With Active Crohn's Disease · Phase 2 · completed
NCT03092765 — Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid · Phase 2 · terminated
NCT02960490 — A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics · Phase 2 · completed
NCT02196558 — A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis · Phase 1, PHASE2 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Eisai Co., Ltd. trials

Trials by the same sponsor.

NCT07515014 — A Study of E6742 in Participants With Systemic Lupus Erythematosus · Phase 2 · not yet recruiting
NCT06793709 — A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast G · recruiting
NCT06657378 — A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized T · recruiting
NCT06322667 — A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab · recruiting
NCT05633108 — A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders · completed

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 NCT02960438 (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: 21 June 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/NCT02960438.

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

NCT02960438

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 (24 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