Trial Outcomes & Findings for Safety and Efficacy of AMG 827 in Subjects With RA (NCT NCT01059448)
NCT ID: NCT01059448
Last Updated: 2022-02-28
Results Overview
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 measurements.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
211 participants
Primary outcome timeframe
Day 1 to Week 52 of study 20090402
Results posted on
2022-02-28
Participant Flow
This was an open-label extension of study 20090061 (NCT00950989). Participants were required to complete the Week 16 visit of study 2009061, sign the informed consent form, complete all screening assessments, if applicable, and meet the safety-based eligibility criteria for study 20090402. 211 participants were enrolled across 45 centers in the United States, Canada, Czech Republic, Bulgaria, Latvia, Mexico, Poland, and the United Kingdom from 03 June 2010 to 18 May 2011.
211 participants were enrolled and all 211 participants received study drug.
Participant milestones
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
55
|
53
|
54
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
49
|
55
|
53
|
54
|
Reasons for withdrawal
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
4
|
|
Overall Study
Disease Progression
|
2
|
1
|
4
|
2
|
|
Overall Study
Administrative Decision
|
43
|
49
|
45
|
46
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of AMG 827 in Subjects With RA
Baseline characteristics by cohort
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=49 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.9 Years
STANDARD_DEVIATION 11.2 • n=93 Participants
|
52.6 Years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
54.6 Years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
51.6 Years
STANDARD_DEVIATION 8.9 • n=483 Participants
|
52.2 Years
STANDARD_DEVIATION 10.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
167 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Race
White or Caucasian
|
34 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
166 Participants
n=36 Participants
|
|
Race
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race
Hispanic or Latino
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Race
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 52 of study 20090402Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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 measurements.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=49 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
|
28 Participants
|
32 Participants
|
31 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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 analysis if an ACR 20 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=47 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=52 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 2
|
21 Participants
|
24 Participants
|
26 Participants
|
24 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 4
|
27 Participants
|
26 Participants
|
24 Participants
|
32 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 8
|
27 Participants
|
31 Participants
|
27 Participants
|
29 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 12
|
25 Participants
|
24 Participants
|
23 Participants
|
22 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 16
|
19 Participants
|
28 Participants
|
23 Participants
|
22 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 20
|
19 Participants
|
24 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 24
|
12 Participants
|
17 Participants
|
17 Participants
|
12 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 36
|
7 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
20090402 Week 48
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=47 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=52 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 2
|
8 Participants
|
8 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 4
|
8 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 8
|
10 Participants
|
9 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 12
|
13 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 16
|
9 Participants
|
7 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 20
|
9 Participants
|
10 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 24
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 36
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Achieved an ACR 50 Response
20090402 Week 48
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=49 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=52 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 36
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 48
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 2
|
0 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 4
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 8
|
5 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 12
|
5 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 16
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 20
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Achieved an ACR 70 Response
20090402 Week 24
|
0 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least 1 dose of AMG 827.
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. Baseline refers to the baseline in parent study 20090061.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=46 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=52 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 2
|
-1.60 Score on a Scale
Standard Deviation 1.02
|
-1.39 Score on a Scale
Standard Deviation 1.26
|
-1.49 Score on a Scale
Standard Deviation 1.22
|
-1.31 Score on a Scale
Standard Deviation 1.07
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 4
|
-1.60 Score on a Scale
Standard Deviation 1.30
|
-1.54 Score on a Scale
Standard Deviation 1.32
|
-1.40 Score on a Scale
Standard Deviation 1.18
|
-1.46 Score on a Scale
Standard Deviation 1.08
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 8
|
-1.69 Score on a Scale
Standard Deviation 1.32
|
-1.65 Score on a Scale
Standard Deviation 1.40
|
-1.50 Score on a Scale
Standard Deviation 1.12
|
-1.64 Score on a Scale
Standard Deviation 1.25
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 12
|
-1.99 Score on a Scale
Standard Deviation 1.08
|
-1.81 Score on a Scale
Standard Deviation 1.29
|
-1.38 Score on a Scale
Standard Deviation 1.39
|
-1.46 Score on a Scale
Standard Deviation 1.15
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 16
|
-2.05 Score on a Scale
Standard Deviation 1.27
|
-1.71 Score on a Scale
Standard Deviation 1.20
|
-1.63 Score on a Scale
Standard Deviation 1.37
|
-1.53 Score on a Scale
Standard Deviation 1.27
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 20
|
-1.94 Score on a Scale
Standard Deviation 1.35
|
-1.70 Score on a Scale
Standard Deviation 1.26
|
-1.61 Score on a Scale
Standard Deviation 1.04
|
-1.52 Score on a Scale
Standard Deviation 1.21
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 24
|
-1.85 Score on a Scale
Standard Deviation 1.00
|
-1.66 Score on a Scale
Standard Deviation 1.12
|
-1.49 Score on a Scale
Standard Deviation 1.21
|
-1.99 Score on a Scale
Standard Deviation 1.38
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 36
|
-1.87 Score on a Scale
Standard Deviation 1.30
|
-1.60 Score on a Scale
Standard Deviation 1.01
|
-1.61 Score on a Scale
Standard Deviation 1.35
|
-1.77 Score on a Scale
Standard Deviation 1.46
|
|
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
20090402 Week 48
|
0.18 Score on a Scale
Standard Deviation NA
Only 1 participant had evaluable data, therefore, standard deviation could not be calculated
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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 Arm "Placebo Q2WK / 210 mg AMG 827 Q2WK" was missing baseline data for DAS28.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=49 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 36
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
Parent Study 20090061 Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Baseline
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 2
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 4
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 8
|
1 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 12
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 16
|
1 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 20
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 24
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With a DAS28 Score < 2.6
20090402 Week 48
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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 baseline data for DAS28.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=49 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
DAS28 Score at All Measured Timepoints
20090402 Week 20
|
4.58 Score on a Scale
Standard Deviation 1.29
|
4.52 Score on a Scale
Standard Deviation 1.27
|
4.73 Score on a Scale
Standard Deviation 1.12
|
4.98 Score on a Scale
Standard Deviation 1.33
|
|
DAS28 Score at All Measured Timepoints
Parent Study 20090061 Baseline
|
6.52 Score on a Scale
Standard Deviation 0.85
|
6.40 Score on a Scale
Standard Deviation 0.78
|
6.45 Score on a Scale
Standard Deviation 0.81
|
6.41 Score on a Scale
Standard Deviation 0.72
|
|
DAS28 Score at All Measured Timepoints
20090402 Baseline
|
5.16 Score on a Scale
Standard Deviation 1.43
|
5.22 Score on a Scale
Standard Deviation 1.30
|
5.33 Score on a Scale
Standard Deviation 1.17
|
5.49 Score on a Scale
Standard Deviation 1.38
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 2
|
4.97 Score on a Scale
Standard Deviation 1.22
|
5.00 Score on a Scale
Standard Deviation 1.32
|
4.96 Score on a Scale
Standard Deviation 1.30
|
5.09 Score on a Scale
Standard Deviation 1.27
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 4
|
5.00 Score on a Scale
Standard Deviation 1.41
|
4.87 Score on a Scale
Standard Deviation 1.29
|
5.06 Score on a Scale
Standard Deviation 1.23
|
4.96 Score on a Scale
Standard Deviation 1.30
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 8
|
4.81 Score on a Scale
Standard Deviation 1.34
|
4.75 Score on a Scale
Standard Deviation 1.33
|
4.97 Score on a Scale
Standard Deviation 1.23
|
4.79 Score on a Scale
Standard Deviation 1.48
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 36
|
4.66 Score on a Scale
Standard Deviation 1.13
|
4.54 Score on a Scale
Standard Deviation 1.15
|
5.06 Score on a Scale
Standard Deviation 1.26
|
4.90 Score on a Scale
Standard Deviation 1.56
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 48
|
7.93 Score on a Scale
Standard Deviation NA
Only 1 participant had evaluable data, therefore, standard deviation could not be calculated
|
—
|
—
|
—
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 12
|
4.64 Score on a Scale
Standard Deviation 1.17
|
4.59 Score on a Scale
Standard Deviation 1.34
|
5.13 Score on a Scale
Standard Deviation 1.32
|
5.02 Score on a Scale
Standard Deviation 1.25
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 16
|
4.61 Score on a Scale
Standard Deviation 1.23
|
4.62 Score on a Scale
Standard Deviation 1.17
|
4.93 Score on a Scale
Standard Deviation 1.38
|
4.94 Score on a Scale
Standard Deviation 1.49
|
|
DAS28 Score at All Measured Timepoints
20090402 Week 24
|
4.71 Score on a Scale
Standard Deviation 1.08
|
4.61 Score on a Scale
Standard Deviation 1.13
|
4.94 Score on a Scale
Standard Deviation 1.19
|
4.57 Score on a Scale
Standard Deviation 1.61
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=49 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
CRP Levels at All Measured Timepoints
Parent Study 20090061 Baseline
|
12.95 Milligrams per Liter (mg/L)
Standard Deviation 11.99
|
14.74 Milligrams per Liter (mg/L)
Standard Deviation 17.50
|
18.91 Milligrams per Liter (mg/L)
Standard Deviation 24.35
|
12.22 Milligrams per Liter (mg/L)
Standard Deviation 10.69
|
|
CRP Levels at All Measured Timepoints
20090402 Baseline
|
11.42 Milligrams per Liter (mg/L)
Standard Deviation 12.13
|
12.23 Milligrams per Liter (mg/L)
Standard Deviation 12.75
|
14.48 Milligrams per Liter (mg/L)
Standard Deviation 18.84
|
12.25 Milligrams per Liter (mg/L)
Standard Deviation 12.49
|
|
CRP Levels at All Measured Timepoints
20090402 Week 2
|
9.67 Milligrams per Liter (mg/L)
Standard Deviation 8.91
|
10.44 Milligrams per Liter (mg/L)
Standard Deviation 10.31
|
18.58 Milligrams per Liter (mg/L)
Standard Deviation 28.49
|
10.56 Milligrams per Liter (mg/L)
Standard Deviation 11.04
|
|
CRP Levels at All Measured Timepoints
20090402 Week 4
|
10.70 Milligrams per Liter (mg/L)
Standard Deviation 10.05
|
12.79 Milligrams per Liter (mg/L)
Standard Deviation 15.91
|
14.46 Milligrams per Liter (mg/L)
Standard Deviation 15.39
|
11.47 Milligrams per Liter (mg/L)
Standard Deviation 11.67
|
|
CRP Levels at All Measured Timepoints
20090402 Week 8
|
9.18 Milligrams per Liter (mg/L)
Standard Deviation 10.51
|
12.19 Milligrams per Liter (mg/L)
Standard Deviation 14.18
|
13.84 Milligrams per Liter (mg/L)
Standard Deviation 15.62
|
13.20 Milligrams per Liter (mg/L)
Standard Deviation 15.11
|
|
CRP Levels at All Measured Timepoints
20090402 Week 12
|
9.07 Milligrams per Liter (mg/L)
Standard Deviation 9.38
|
12.61 Milligrams per Liter (mg/L)
Standard Deviation 14.61
|
15.68 Milligrams per Liter (mg/L)
Standard Deviation 14.82
|
14.54 Milligrams per Liter (mg/L)
Standard Deviation 13.25
|
|
CRP Levels at All Measured Timepoints
20090402 Week 16
|
12.09 Milligrams per Liter (mg/L)
Standard Deviation 12.69
|
12.91 Milligrams per Liter (mg/L)
Standard Deviation 20.22
|
16.01 Milligrams per Liter (mg/L)
Standard Deviation 17.40
|
12.92 Milligrams per Liter (mg/L)
Standard Deviation 11.70
|
|
CRP Levels at All Measured Timepoints
20090402 Week 20
|
10.21 Milligrams per Liter (mg/L)
Standard Deviation 12.13
|
10.59 Milligrams per Liter (mg/L)
Standard Deviation 12.05
|
14.14 Milligrams per Liter (mg/L)
Standard Deviation 16.69
|
14.79 Milligrams per Liter (mg/L)
Standard Deviation 18.38
|
|
CRP Levels at All Measured Timepoints
20090402 Week 24
|
7.99 Milligrams per Liter (mg/L)
Standard Deviation 5.82
|
8.76 Milligrams per Liter (mg/L)
Standard Deviation 9.16
|
16.50 Milligrams per Liter (mg/L)
Standard Deviation 21.01
|
9.41 Milligrams per Liter (mg/L)
Standard Deviation 10.04
|
|
CRP Levels at All Measured Timepoints
20090402 Week 36
|
8.49 Milligrams per Liter (mg/L)
Standard Deviation 9.96
|
9.92 Milligrams per Liter (mg/L)
Standard Deviation 12.22
|
12.02 Milligrams per Liter (mg/L)
Standard Deviation 17.38
|
8.89 Milligrams per Liter (mg/L)
Standard Deviation 8.71
|
|
CRP Levels at All Measured Timepoints
20090402 Week 48
|
22.10 Milligrams per Liter (mg/L)
Standard Deviation NA
Only 1 participant had evaluable data, therefore, standard deviation could not be calculated
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
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.
Outcome measures
| Measure |
Placebo Q2WK / 210 mg AMG 827 Q2WK
n=49 Participants
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 Participants
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 Participants
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 Participants
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
ESR at All Measured Timepoints
20090402 Week 36
|
36.62 millimeters per hour (mm/hr)
Standard Deviation 16.19
|
38.69 millimeters per hour (mm/hr)
Standard Deviation 23.22
|
36.85 millimeters per hour (mm/hr)
Standard Deviation 18.07
|
38.07 millimeters per hour (mm/hr)
Standard Deviation 26.39
|
|
ESR at All Measured Timepoints
Parent Study 20090061 Baseline
|
50.12 millimeters per hour (mm/hr)
Standard Deviation 20.53
|
44.27 millimeters per hour (mm/hr)
Standard Deviation 18.72
|
45.81 millimeters per hour (mm/hr)
Standard Deviation 21.97
|
45.06 millimeters per hour (mm/hr)
Standard Deviation 20.03
|
|
ESR at All Measured Timepoints
20090402 Baseline
|
38.35 millimeters per hour (mm/hr)
Standard Deviation 27.78
|
38.15 millimeters per hour (mm/hr)
Standard Deviation 23.79
|
41.89 millimeters per hour (mm/hr)
Standard Deviation 22.27
|
39.15 millimeters per hour (mm/hr)
Standard Deviation 24.70
|
|
ESR at All Measured Timepoints
20090402 Week 2
|
36.78 millimeters per hour (mm/hr)
Standard Deviation 21.43
|
36.83 millimeters per hour (mm/hr)
Standard Deviation 27.11
|
37.65 millimeters per hour (mm/hr)
Standard Deviation 19.24
|
37.00 millimeters per hour (mm/hr)
Standard Deviation 25.23
|
|
ESR at All Measured Timepoints
20090402 Week 4
|
39.27 millimeters per hour (mm/hr)
Standard Deviation 23.73
|
36.07 millimeters per hour (mm/hr)
Standard Deviation 21.44
|
40.53 millimeters per hour (mm/hr)
Standard Deviation 23.50
|
38.31 millimeters per hour (mm/hr)
Standard Deviation 24.70
|
|
ESR at All Measured Timepoints
20090402 Week 8
|
37.40 millimeters per hour (mm/hr)
Standard Deviation 23.26
|
34.65 millimeters per hour (mm/hr)
Standard Deviation 23.14
|
38.43 millimeters per hour (mm/hr)
Standard Deviation 19.50
|
35.55 millimeters per hour (mm/hr)
Standard Deviation 23.52
|
|
ESR at All Measured Timepoints
20090402 Week 12
|
36.31 millimeters per hour (mm/hr)
Standard Deviation 18.30
|
36.09 millimeters per hour (mm/hr)
Standard Deviation 24.30
|
42.28 millimeters per hour (mm/hr)
Standard Deviation 22.74
|
39.30 millimeters per hour (mm/hr)
Standard Deviation 22.54
|
|
ESR at All Measured Timepoints
20090402 Week 16
|
38.21 millimeters per hour (mm/hr)
Standard Deviation 23.08
|
40.27 millimeters per hour (mm/hr)
Standard Deviation 26.07
|
43.78 millimeters per hour (mm/hr)
Standard Deviation 23.23
|
39.43 millimeters per hour (mm/hr)
Standard Deviation 22.81
|
|
ESR at All Measured Timepoints
20090402 Week 20
|
43.41 millimeters per hour (mm/hr)
Standard Deviation 28.27
|
35.16 millimeters per hour (mm/hr)
Standard Deviation 24.73
|
38.00 millimeters per hour (mm/hr)
Standard Deviation 26.25
|
40.48 millimeters per hour (mm/hr)
Standard Deviation 26.71
|
|
ESR at All Measured Timepoints
20090402 Week 24
|
42.83 millimeters per hour (mm/hr)
Standard Deviation 25.05
|
41.07 millimeters per hour (mm/hr)
Standard Deviation 23.14
|
40.58 millimeters per hour (mm/hr)
Standard Deviation 21.12
|
42.62 millimeters per hour (mm/hr)
Standard Deviation 27.23
|
|
ESR at All Measured Timepoints
20090402 Week 48
|
65.00 millimeters per hour (mm/hr)
Standard Deviation NA
Only 1 participant had evaluable data, therefore, standard deviation could not be calculated
|
—
|
—
|
—
|
Adverse Events
Placebo / AMG 827 210 mg Q2WK
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo / AMG 827 210 mg Q2WK
n=49 participants at risk
Participants who were administered matching placebo in parent study 2009061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also received weekly intramuscular, oral or SC doses of methotrexate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 participants at risk
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 participants at risk
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 participants at risk
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
General disorders
Chest pain
|
2.0%
1/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.9%
1/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
Other adverse events
| Measure |
Placebo / AMG 827 210 mg Q2WK
n=49 participants at risk
Participants who were administered matching placebo in parent study 2009061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also received weekly intramuscular, oral or SC doses of methotrexate.
|
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=55 participants at risk
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
n=53 participants at risk
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
n=54 participants at risk
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.9%
1/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.6%
3/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.5%
3/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.9%
1/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
7.3%
4/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.9%
1/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.6%
3/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
General disorders
Injection site pain
|
10.2%
5/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
3.8%
2/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.6%
3/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
7.3%
4/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
7.5%
4/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
3.7%
2/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
5/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.5%
3/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
13.2%
7/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
7.4%
4/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.9%
1/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.6%
3/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
4/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.5%
3/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
3.8%
2/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.6%
3/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
1.8%
1/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.7%
3/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
0.00%
0/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
4.1%
2/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.5%
3/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
7.5%
4/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.6%
3/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
7.3%
4/55 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
5.7%
3/53 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
3.7%
2/54 • From first dose of study drug in 20090402 until the end of study (maximum duration was 366 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER