NCT01059448 is a Phase 2 clinical trial of AMG 827 in Rheumatoid Arthritis, sponsored by Amgen.

Who is sponsoring NCT01059448?

NCT01059448 is sponsored by Amgen.

What drugs are being tested in NCT01059448?

Interventions in NCT01059448: AMG 827.

What condition does NCT01059448 study?

NCT01059448 studies Rheumatoid Arthritis.

Is NCT01059448 still recruiting?

NCT01059448 is currently terminated. Last updated 28 February 2022.

Are results published for NCT01059448?

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

Last reviewed 2022-02-28 · How we verify

NCT01059448

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

Safety and Efficacy of AMG 827 in Subjects With RA

Terminated Phase 2 Results posted Last updated 28 February 2022

What this trial tests

Phase 2 trial testing AMG 827 in Rheumatoid Arthritis in 211 participants. Terminated before completion.

Timeline

3 June 2010

Primary endpoint
5 April 2011

5 April 2011

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	211
Start date	3 June 2010
Primary completion	5 April 2011
Estimated completion	5 April 2011
Sites	44 locations across United Kingdom, Poland, Mexico, Canada, Bulgaria, Czechia, United States, Latvia

Drugs / interventions tested

AMG 827 — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Amgen — full company profile →

Who can join

Eligibility, 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.

Number of Participants With a Treatment-emergent Adverse Event (TEAE) Primary · Day 1 to Week 52 of study 20090402

A TEAE was defined as an event that occurred after the first dose date and before the end of study date in study 20090402; or an event that was already present prior to the initiation of the investigational product (i.e. present at study 20090402) baseline but worsened in either frequency or severity after the first dose date and before the end of study date in study 20090402. TEAEs also included serious treatment-emergent adverse events and clinically significant changes from baseline in hematology, chemistry and urinalysis profiles and clinically significant changes in vital sign measuremen

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	28
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	32
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	31
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	32

Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

An ACR 20 response was defined as at least a 20% improvement from baseline in both tender/painful and swollen joint counts, and a 20% improvement or more in at least 3 of the following 5 criteria: physician global assessment of disease activity (PGA), subject global assessment of disease activity (SGA), participant global assessment of joint pain, participant self-assessment of disability (Health Assessment Questionnaire, HAQ-DI), and acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever had a bigger improvement. Participants were excluded from analy

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	21
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	24
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	26
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	24

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	27
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	26
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	24
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	32

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	27
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	31
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	27
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	29

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	25
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	24
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	23
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	22

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	19
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	28
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	23
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	22

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	19
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	24
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	15
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	15

20090402 Week 24

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	12
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	17
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	17
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12

20090402 Week 36

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	7
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	6
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	5
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	7

Number of Participants Who Achieved an ACR 50 Response Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

An ACR 50 response was defined as at least a 50% improvement from baseline in both tender/painful and swollen joint counts, and a 50% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 50 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061.

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	8
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	8
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	12
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	7

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	8
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	10
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	10
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	9
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	13
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	11

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	13
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	10
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	9
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	7
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	12
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	11

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	9
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	5
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	8

20090402 Week 24

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	6
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	6
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	6
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	9

20090402 Week 36

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	4
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	2
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2

Number of Participants Who Achieved an ACR 70 Response Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

An ACR 70 response was defined as at least a 70% improvement from baseline in both tender/painful and swollen joint counts, and a 70% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 70 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061.

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	0
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	3
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	2
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	3
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	5
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	1
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	5
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	2
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	3
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	3
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	5
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	4
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	3
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	1
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	1

20090402 Week 24

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	0
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	2
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	6

20090402 Week 36

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	0
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	0
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	1
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2

Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A negative change from baseline indicated a reduction in disease activity. B

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-1.60	± 1.02
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.39	± 1.26
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.49	± 1.22
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.31	± 1.07

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-1.60	± 1.30
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.54	± 1.32
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.40	± 1.18
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.46	± 1.08

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-1.69	± 1.32
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.65	± 1.40
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.50	± 1.12
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.64	± 1.25

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-1.99	± 1.08
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.81	± 1.29
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.38	± 1.39
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.46	± 1.15

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-2.05	± 1.27
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.71	± 1.20
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.63	± 1.37
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.53	± 1.27

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-1.94	± 1.35
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.70	± 1.26
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.61	± 1.04
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.52	± 1.21

20090402 Week 24

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-1.85	± 1.00
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.66	± 1.12
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.49	± 1.21
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.99	± 1.38

20090402 Week 36

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	-1.87	± 1.30
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.60	± 1.01
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	-1.61	± 1.35
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	-1.77	± 1.46

Number of Participants With a DAS28 Score < 2.6 Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A score of \<2.6 indicated disease activity remission. 1 participant in the

Parent Study 20090061 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	0
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	0
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	0
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	0

20090402 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	2
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	0
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	0
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	3
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	1
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	1

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	1
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	1
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	1

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	1
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	3
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	0
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	2
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	6
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	0
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	1

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	1
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	1
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	1
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	2
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	1
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	1

DAS28 Score at All Measured Timepoints Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. 1 participant in the Arm "Placebo Q2WK / 210 mg AMG 827 Q2WK" was missing ba

Parent Study 20090061 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	6.52	± 0.85
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	6.40	± 0.78
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	6.45	± 0.81
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	6.41	± 0.72

20090402 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	5.16	± 1.43
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5.22	± 1.30
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	5.33	± 1.17
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5.49	± 1.38

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	4.97	± 1.22
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5.00	± 1.32
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	4.96	± 1.30
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5.09	± 1.27

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	5.00	± 1.41
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.87	± 1.29
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	5.06	± 1.23
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.96	± 1.30

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	4.81	± 1.34
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.75	± 1.33
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	4.97	± 1.23
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.79	± 1.48

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	4.64	± 1.17
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.59	± 1.34
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	5.13	± 1.32
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	5.02	± 1.25

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	4.61	± 1.23
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.62	± 1.17
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	4.93	± 1.38
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.94	± 1.49

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	4.58	± 1.29
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.52	± 1.27
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	4.73	± 1.12
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	4.98	± 1.33

CRP Levels at All Measured Timepoints Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

All blood samples were taken before the dose of IP was administered. Blood samples were processed and sent to the central laboratory. The central laboratory were responsible for completing assessments.

Parent Study 20090061 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	12.95	± 11.99
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	14.74	± 17.50
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	18.91	± 24.35
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.22	± 10.69

20090402 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	11.42	± 12.13
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.23	± 12.75
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	14.48	± 18.84
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.25	± 12.49

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	9.67	± 8.91
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10.44	± 10.31
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	18.58	± 28.49
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10.56	± 11.04

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	10.70	± 10.05
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.79	± 15.91
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	14.46	± 15.39
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	11.47	± 11.67

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	9.18	± 10.51
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.19	± 14.18
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	13.84	± 15.62
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	13.20	± 15.11

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	9.07	± 9.38
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.61	± 14.61
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	15.68	± 14.82
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	14.54	± 13.25

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	12.09	± 12.69
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.91	± 20.22
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	16.01	± 17.40
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	12.92	± 11.70

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	10.21	± 12.13
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	10.59	± 12.05
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	14.14	± 16.69
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	14.79	± 18.38

ESR at All Measured Timepoints Primary · Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.

All blood samples were taken before the dose of IP was administered. ESR was performed locally at each site and the ESR data was submitted to the central laboratory.

Parent Study 20090061 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	50.12	± 20.53
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	44.27	± 18.72
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	45.81	± 21.97
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	45.06	± 20.03

20090402 Baseline

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	38.35	± 27.78
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	38.15	± 23.79
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	41.89	± 22.27
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	39.15	± 24.70

20090402 Week 2

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	36.78	± 21.43
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	36.83	± 27.11
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	37.65	± 19.24
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	37.00	± 25.23

20090402 Week 4

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	39.27	± 23.73
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	36.07	± 21.44
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	40.53	± 23.50
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	38.31	± 24.70

20090402 Week 8

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	37.40	± 23.26
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	34.65	± 23.14
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	38.43	± 19.50
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	35.55	± 23.52

20090402 Week 12

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	36.31	± 18.30
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	36.09	± 24.30
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	42.28	± 22.74
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	39.30	± 22.54

20090402 Week 16

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	38.21	± 23.08
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	40.27	± 26.07
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	43.78	± 23.23
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	39.43	± 22.81

20090402 Week 20

Group	Value	95% CI
Placebo Q2WK / 210 mg AMG 827 Q2WK	43.41	± 28.27
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	35.16	± 24.73
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK	38.00	± 26.25
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK	40.48	± 26.71

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo / AMG 827 210 mg Q2WK

Serious: 2/49 (4%)

Deaths: —

70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK

Serious: 5/55 (9%)

Deaths: —

140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK

Serious: 1/53 (2%)

Deaths: —

210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK

Serious: 0/54 (0%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	Placebo / AMG 827 210 mg Q…	70 mg AMG 827 Q2WK / 210 m…	140mg AMG 827 Q2WK / 210mg…	210 mg AMG 827 Q2WK / 210 …
Dysphagia	Gastrointestinal disorders	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—
Oesophageal achalasia	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—
Hypersensitivity	Immune system disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Traumatic brain injury	Injury, poisoning and procedural complications	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Completed suicide	Psychiatric disorders	—	—	—	—
Nephrotic syndrome	Renal and urinary disorders	—	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Placebo / AMG 827 210 mg Q…	70 mg AMG 827 Q2WK / 210 m…	140mg AMG 827 Q2WK / 210mg…	210 mg AMG 827 Q2WK / 210 …
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—
Conjunctivitis	Eye disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—

Most-reported serious reactions: Dysphagia, Gastritis, Oesophageal achalasia, Chest pain, Cholelithiasis, Hypersensitivity, Pneumonia, Traumatic brain injury.

Data from ClinicalTrials.gov NCT01059448 adverse events section.

Sponsor's own description

This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989). All subjects in this study will receive a 210mg injection of AMG827 for treatment for their Rheumatoid Arthritis for up to 5 years.

Publications & conference data

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

Much More Than IL-17A: Cytokines of the IL-17 Family Between Microbiota and Cancer.
Brevi A, Cogrossi LL, Grazia G, Masciovecchio D, et al · · 2020 · cited 81× · PMID 33244315 · DOI 10.3389/fimmu.2020.565470

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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 NCT01059448 (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 Amgen
Last refreshed: 28 February 2022

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/NCT01059448.

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

NCT01059448

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 (11 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of AMG 827

Other recruiting trials for Rheumatoid Arthritis

Other Amgen trials

Verify against primary sources