Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis (NCT NCT01050998)

Last Updated: 2018-06-25

Results Overview

DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per Liter \[mg/L\]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (\<) 3.2 = low disease activity, greater than or equal to (\>=) 3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

516 participants

Primary outcome timeframe

Day 85

Results posted on

2018-06-25

Participant Flow

A total of 516 participants were screened out of which 290 participants were randomized in the study.

Participant milestones

Participant milestones
Measure	Mavrilimumab 10 mg Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Placebo Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Study STARTED	48	49	49	48	96
Overall Study COMPLETED	44	47	46	45	82
Overall Study NOT COMPLETED	4	2	3	3	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Mavrilimumab 10 mg Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Placebo Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Study Adverse Event	1	0	1	0	2
Overall Study Withdrawal by Subject	0	0	0	1	3
Overall Study Other	3	2	1	1	5
Overall Study Data integrity issues	0	0	1	1	4

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Total n=284 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 11.9 • n=5 Participants	51.1 years STANDARD_DEVIATION 12.1 • n=7 Participants	52.7 years STANDARD_DEVIATION 10.3 • n=5 Participants	50.1 years STANDARD_DEVIATION 12.1 • n=4 Participants	52.1 years STANDARD_DEVIATION 12.8 • n=21 Participants	51.7 years STANDARD_DEVIATION 11.9 • n=10 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	43 Participants n=7 Participants	44 Participants n=5 Participants	40 Participants n=4 Participants	82 Participants n=21 Participants	248 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	10 Participants n=21 Participants	36 Participants n=10 Participants

PRIMARY outcome

Timeframe: Day 85

Population: The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85	32.6 percentage of participants	37.5 percentage of participants	63.3 percentage of participants	47.9 percentage of participants	68.1 percentage of participants

PRIMARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for the specified region for each arm, respectively.

DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region European Region (n=75, 39, 41, 39, 39)	34.7 percentage of participants	41.0 percentage of participants	61.0 percentage of participants	51.3 percentage of participants	66.7 percentage of participants
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region Japanese Region (n=17, 9, 8, 9, 8)	23.5 percentage of participants	22.2 percentage of participants	75.0 percentage of participants	33.3 percentage of participants	75.0 percentage of participants

PRIMARY outcome

Timeframe: Day 85

DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85	37.0 percentage of participants	50.0 percentage of participants	61.2 percentage of participants	58.3 percentage of participants	66.0 percentage of participants

PRIMARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region European Region (n=75, 39, 41, 39, 39)	41.3 percentage of participants	51.3 percentage of participants	58.5 percentage of participants	61.5 percentage of participants	64.1 percentage of participants
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region Japanese Region (n=17, 9, 8, 9, 8)	17.6 percentage of participants	44.4 percentage of participants	75.0 percentage of participants	44.4 percentage of participants	75.0 percentage of participants

PRIMARY outcome

Timeframe: Day 85

DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (CRP) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (CRP) \>=3.2 to less than or equal to (=\<) 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (CRP) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (CRP) \>5.1.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 No response	51.1 percentage of participants	47.9 percentage of participants	28.6 percentage of participants	35.4 percentage of participants	23.4 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 Moderate response	34.8 percentage of participants	31.3 percentage of participants	38.8 percentage of participants	41.7 percentage of participants	42.6 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 Good response	14.1 percentage of participants	20.8 percentage of participants	32.7 percentage of participants	22.9 percentage of participants	34.0 percentage of participants

PRIMARY outcome

Timeframe: Day 85

DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (CRP) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (CRP) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (CRP) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (CRP) \>5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region European: No response (n=75,39,41,39,39)	49.3 percentage of participants	46.2 percentage of participants	29.3 percentage of participants	33.3 percentage of participants	23.1 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region European: Moderate response (n=75,39,41,39,39)	36.0 percentage of participants	33.3 percentage of participants	41.5 percentage of participants	41.0 percentage of participants	46.2 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region European: Good response (n=75,39,41,39,39)	14.7 percentage of participants	20.5 percentage of participants	29.3 percentage of participants	25.6 percentage of participants	30.8 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region Japanese: No response (n=17,9,8,9,8)	58.8 percentage of participants	55.6 percentage of participants	25.0 percentage of participants	44.4 percentage of participants	25.0 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region Japanese: Moderate response (n=17,9,8,9,8)	29.4 percentage of participants	22.2 percentage of participants	25.0 percentage of participants	44.4 percentage of participants	25.0 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region Japanese: Good response (n=17,9,8,9,8)	11.8 percentage of participants	22.2 percentage of participants	50.0 percentage of participants	11.1 percentage of participants	50.0 percentage of participants

PRIMARY outcome

Timeframe: Day 85

DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (ESR) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (ESR) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (ESR) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (ESR) \>5.1.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 No response	55.4 percentage of participants	39.6 percentage of participants	36.7 percentage of participants	33.3 percentage of participants	25.5 percentage of participants
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 Moderate response	35.9 percentage of participants	45.8 percentage of participants	44.9 percentage of participants	54.2 percentage of participants	53.2 percentage of participants
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 Good response	8.7 percentage of participants	14.6 percentage of participants	18.4 percentage of participants	12.5 percentage of participants	21.3 percentage of participants

PRIMARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region European: No response (n=75,39,41,39,39)	53.3 percentage of participants	38.5 percentage of participants	39.0 percentage of participants	33.3 percentage of participants	28.2 percentage of participants
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region European: Moderate response (n=75,39,41,39,39)	38.7 percentage of participants	46.2 percentage of participants	43.9 percentage of participants	53.8 percentage of participants	51.3 percentage of participants
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region European: Good response (n=75,39,41,39,39)	8.0 percentage of participants	15.4 percentage of participants	17.1 percentage of participants	12.8 percentage of participants	20.5 percentage of participants
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region Japanese: No response (n=17,9,8,9,8)	64.7 percentage of participants	44.4 percentage of participants	25.0 percentage of participants	33.3 percentage of participants	12.5 percentage of participants
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region Japanese: Moderate response (n=17,9,8,9,8)	23.5 percentage of participants	44.4 percentage of participants	50.0 percentage of participants	55.6 percentage of participants	62.5 percentage of participants
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region Japanese: Good response (n=17,9,8,9,8)	11.8 percentage of participants	11.1 percentage of participants	25.0 percentage of participants	11.1 percentage of participants	25.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline up to Day 169 (follow-up)

Population: The safety population included all participants who received any dose of investigational product.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up Day 169 that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs	46 participants	33 participants	31 participants	26 participants	28 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAEs	1 participants	2 participants	2 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to Day 169 (follow-up)

Population: The safety population included all participants who received any dose of investigational product.

Vital sign assessments included blood pressure, pulse rate, temperature, and respiration rate. Vital signs abnormalities reported as TEAEs were reported.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) Pyrexia	1 participants	0 participants	0 participants	2 participants	0 participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) Hypertension	2 participants	0 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to Day 169 (follow-up)

Population: The safety population included all participants who received any dose of investigational product.

12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator's discretion were reported.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Number of Participants With Abnormal Electrocardiogram (ECG) Results	0 participants	1 participants	0 participants	0 participants	2 participants

PRIMARY outcome

Timeframe: Day 85

FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=46 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 FEV1	2.730 liters Standard Deviation 0.764	2.877 liters Standard Deviation 0.821	2.949 liters Standard Deviation 0.722	2.701 liters Standard Deviation 0.489	2.793 liters Standard Deviation 0.690
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 FVC	3.439 liters Standard Deviation 0.949	3.582 liters Standard Deviation 0.967	3.667 liters Standard Deviation 0.882	3.370 liters Standard Deviation 0.527	3.499 liters Standard Deviation 0.766

PRIMARY outcome

Timeframe: Day 85

Population: The safety population included all participants who received any dose of investigational product. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for the specified region for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=46 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region European: FEV1 (n=71,37,39,40,39)	2.811 liters Standard Deviation 0.790	2.902 liters Standard Deviation 0.810	3.042 liters Standard Deviation 0.745	2.698 liters Standard Deviation 0.501	2.848 liters Standard Deviation 0.699
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region Japanese: FVC (n=16,9,8,9,8)	3.005 liters Standard Deviation 0.534	3.378 liters Standard Deviation 1.076	3.119 liters Standard Deviation 0.370	3.434 liters Standard Deviation 0.505	3.235 liters Standard Deviation 0.725
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region European: FVC (n=71,37,39,40,39)	3.537 liters Standard Deviation 0.996	3.632 liters Standard Deviation 0.948	3.779 liters Standard Deviation 0.917	3.355 liters Standard Deviation 0.537	3.553 liters Standard Deviation 0.772
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region Japanese: FEV1 (n=16,9,8,9,8)	2.367 liters Standard Deviation 0.510	2.774 liters Standard Deviation 0.908	2.493 liters Standard Deviation 0.354	2.712 liters Standard Deviation 0.457	2.520 liters Standard Deviation 0.616

PRIMARY outcome

Timeframe: Baseline and Day 85

Population: The safety population included all participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure at the specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 Baseline: FEV1 (n=87,43,45,49,48)	2.790 liters Standard Deviation 0.770	2.788 liters Standard Deviation 0.773	2.990 liters Standard Deviation 0.765	2.760 liters Standard Deviation 0.430	2.831 liters Standard Deviation 0.681
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 Change at Day 85: FEV1 (n=87,46,47,49,47)	-0.039 liters Standard Deviation 0.234	0.044 liters Standard Deviation 0.231	0.016 liters Standard Deviation 0.196	-0.059 liters Standard Deviation 0.249	-0.049 liters Standard Deviation 0.221
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 Baseline: FVC (n=87,43,45,49,48)	3.456 liters Standard Deviation 0.948	3.486 liters Standard Deviation 0.963	3.759 liters Standard Deviation 0.868	3.409 liters Standard Deviation 0.496	3.506 liters Standard Deviation 0.804
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 Change at Day 85: FVC (n=87,46,47,49,47)	-0.012 liters Standard Deviation 0.301	0.048 liters Standard Deviation 0.243	-0.013 liters Standard Deviation 0.239	-0.039 liters Standard Deviation 0.268	-0.017 liters Standard Deviation 0.218

PRIMARY outcome

Timeframe: Day 85

DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=46 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85	91.7 percent diffusion capacity Standard Deviation 16.7	95.0 percent diffusion capacity Standard Deviation 16.2	95.0 percent diffusion capacity Standard Deviation 15.1	95.0 percent diffusion capacity Standard Deviation 15.7	89.3 percent diffusion capacity Standard Deviation 12.0

PRIMARY outcome

Timeframe: Day 85

DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=46 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region European region: (n=71,37,39,40,39)	90.4 percent diffusion capacity Standard Deviation 16.5	96.0 percent diffusion capacity Standard Deviation 16.9	94.0 percent diffusion capacity Standard Deviation 15.2	94.8 percent diffusion capacity Standard Deviation 16.5	88.6 percent diffusion capacity Standard Deviation 10.7
Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region Japanese region (n=16,9,8,9,8)	97.6 percent diffusion capacity Standard Deviation 16.9	91.0 percent diffusion capacity Standard Deviation 13.3	100.1 percent diffusion capacity Standard Deviation 14.6	96.0 percent diffusion capacity Standard Deviation 12.6	93.0 percent diffusion capacity Standard Deviation 17.2

PRIMARY outcome

Timeframe: Baseline and Day 85

DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 Baseline (n=86,40,45,49,48)	91.5 percent diffusion capacity Standard Deviation 12.5	96.3 percent diffusion capacity Standard Deviation 17.7	93.7 percent diffusion capacity Standard Deviation 15.5	97.5 percent diffusion capacity Standard Deviation 14.8	92.5 percent diffusion capacity Standard Deviation 13.7
Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 Change at Day 85 (n=87,46,47,49,47)	0.1 percent diffusion capacity Standard Deviation 14.3	-3.1 percent diffusion capacity Standard Deviation 17.3	0.4 percent diffusion capacity Standard Deviation 11.1	-2.5 percent diffusion capacity Standard Deviation 10.8	-3.7 percent diffusion capacity Standard Deviation 11.3

PRIMARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=89 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Dyspnea Score at Day 85	0.25 units on a scale Standard Deviation 0.48	0.13 units on a scale Standard Deviation 0.38	0.35 units on a scale Standard Deviation 0.70	0.15 units on a scale Standard Deviation 0.44	0.35 units on a scale Standard Deviation 0.59

PRIMARY outcome

Timeframe: Baseline and Day 85

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Change From Baseline in Dyspnea Score at Day 85 Baseline (n=96,48,49,49,48)	0.29 units on a scale Standard Deviation 0.58	0.26 units on a scale Standard Deviation 0.88	0.26 units on a scale Standard Deviation 0.59	0.19 units on a scale Standard Deviation 0.49	0.32 units on a scale Standard Deviation 0.59
Change From Baseline in Dyspnea Score at Day 85 Change at Day 85 (n=89,45,47,49,47)	-0.06 units on a scale Standard Deviation 0.53	-0.14 units on a scale Standard Deviation 0.62	0.10 units on a scale Standard Deviation 0.44	-0.04 units on a scale Standard Deviation 0.35	0.02 units on a scale Standard Deviation 0.56

PRIMARY outcome

Timeframe: Day 85

Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above).

Outcome measures

Outcome measures
Measure	Placebo n=89 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Categorized Dyspnea Score at Day 85 No/Slight breathlessness	89 participants 0.58	45 participants 0.88	45 participants 0.59	49 participants 0.49	46 participants 0.59
Categorized Dyspnea Score at Day 85 Moderate breathlessness	0 participants 0.53	0 participants 0.62	2 participants 0.44	0 participants 0.35	1 participants 0.56
Categorized Dyspnea Score at Day 85 Severe breathlessness	0 participants	0 participants	0 participants	0 participants	0 participants
Categorized Dyspnea Score at Day 85 Very severe breathlessness	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 85

Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Oxygen Saturation Level at Day 85	97.5 percent saturation Standard Deviation 1.2	97.6 percent saturation Standard Deviation 1.3	97.7 percent saturation Standard Deviation 1.3	97.2 percent saturation Standard Deviation 1.8	97.3 percent saturation Standard Deviation 1.5

PRIMARY outcome

Timeframe: Day 85

Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Oxygen Saturation Level at Day 85 by Region Japanese region: (n=16,9,8,9,8)	97.6 percent saturation Standard Deviation 0.9	97.4 percent saturation Standard Deviation 1.0	98.4 percent saturation Standard Deviation 1.1	97.4 percent saturation Standard Deviation 0.7	97.3 percent saturation Standard Deviation 1.3
Oxygen Saturation Level at Day 85 by Region European region: (n=72,36,39,40,39)	97.5 percent saturation Standard Deviation 1.3	97.6 percent saturation Standard Deviation 1.3	97.6 percent saturation Standard Deviation 1.3	97.2 percent saturation Standard Deviation 2.0	97.3 percent saturation Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline and Day 85

Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Change From Baseline in Oxygen Saturation Level at Day 85 Baseline (n=96,48,49,49,48)	97.5 percent saturation Standard Deviation 1.3	97.8 percent saturation Standard Deviation 1.6	97.6 percent saturation Standard Deviation 1.2	97.6 percent saturation Standard Deviation 1.4	97.2 percent saturation Standard Deviation 1.7
Change From Baseline in Oxygen Saturation Level at Day 85 Change at Day 85 (n=88,45,47,49,47)	0.0 percent saturation Standard Deviation 1.5	-0.2 percent saturation Standard Deviation 1.5	0.1 percent saturation Standard Deviation 1.4	-0.3 percent saturation Standard Deviation 1.9	0.1 percent saturation Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline up to Day 169 (follow-up)

Population: The safety population included all participants who received any dose of investigational product.

Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite).

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=49 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=48 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) Blood and lymphatic system disorders	10 participants	3 participants	3 participants	3 participants	4 participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) Hepatic abnormality	3 participants	5 participants	3 participants	2 participants	3 participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) Blood cholesterol increased	0 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) Blood triglycerides increased	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) Hyperglycemia	1 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) Urinalysis abnormalities	3 participants	0 participants	3 participants	1 participants	0 participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) Hypercholesterolemia	1 participants	1 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Day 85

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 DAS28(ESR): Baseline: (n=92,48,49,48,47)	6.18 units on a scale Standard Error 0.118	6.06 units on a scale Standard Error 0.165	6.31 units on a scale Standard Error 0.145	5.98 units on a scale Standard Error 0.163	6.06 units on a scale Standard Error 0.119
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 DAS28(ESR): Change at Day 85 (n=85,45,47,48,46)	-1.04 units on a scale Standard Error 0.125	-1.39 units on a scale Standard Error 0.172	-1.80 units on a scale Standard Error 0.170	-1.46 units on a scale Standard Error 0.168	-1.84 units on a scale Standard Error 0.172
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 DAS28(CRP): Baseline (n=92,48,49,48,47)	5.43 units on a scale Standard Error 0.110	5.24 units on a scale Standard Error 0.160	5.42 units on a scale Standard Error 0.139	5.14 units on a scale Standard Error 0.146	5.34 units on a scale Standard Error 0.115
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 DAS28(CRP): Change at Day 85 (n=84,45,46,48,46)	-0.97 units on a scale Standard Error 0.120	-1.27 units on a scale Standard Error 0.166	-1.63 units on a scale Standard Error 0.163	-1.32 units on a scale Standard Error 0.162	-1.70 units on a scale Standard Error 0.165

SECONDARY outcome

Timeframe: Baseline and Day 85

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region Japanese: DAS28(CRP): Baseline (n=17,9,8,9,8)	4.75 units on a scale Standard Error 0.242	5.00 units on a scale Standard Error 0.427	5.12 units on a scale Standard Error 0.306	4.32 units on a scale Standard Error 0.268	5.04 units on a scale Standard Error 0.413
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region Japanese: DAS28(CRP): Day 85 (n=16,9,8,9,8)	-0.85 units on a scale Standard Error 0.281	-0.73 units on a scale Standard Error 0.358	-2.04 units on a scale Standard Error 0.381	-0.89 units on a scale Standard Error 0.361	-1.71 units on a scale Standard Error 0.380
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region European: DAS28(ESR): Day 85 (n=69,36,39,39,38)	-1.12 units on a scale Standard Error 0.140	-1.51 units on a scale Standard Error 0.196	-1.76 units on a scale Standard Error 0.190	-1.53 units on a scale Standard Error 0.190	-1.85 units on a scale Standard Error 0.193
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region Japanese: DAS28(ESR): Baseline (n=17,9,8,9,8)	5.38 units on a scale Standard Error 0.248	5.87 units on a scale Standard Error 0.426	6.05 units on a scale Standard Error 0.309	4.93 units on a scale Standard Error 0.379	5.78 units on a scale Standard Error 0.404
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region Japanese: DAS28(ESR): Day 85 (n=16,9,8,9,8)	-0.74 units on a scale Standard Error 0.276	-0.83 units on a scale Standard Error 0.359	-1.99 units on a scale Standard Error 0.382	-1.24 units on a scale Standard Error 0.362	-1.78 units on a scale Standard Error 0.380
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region European: DAS28(CRP): Baseline (n=75,39,41,39,39)	5.58 units on a scale Standard Error 0.117	5.30 units on a scale Standard Error 0.172	5.48 units on a scale Standard Error 0.154	5.33 units on a scale Standard Error 0.155	5.41 units on a scale Standard Error 0.111
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region European: DAS28(CRP): Day 85 (n=68,36,38,39,38)	-1.00 units on a scale Standard Error 0.133	-1.40 units on a scale Standard Error 0.187	-1.55 units on a scale Standard Error 0.181	-1.43 units on a scale Standard Error 0.181	-1.70 units on a scale Standard Error 0.183
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region European: DAS28(ESR): Baseline (n=75,39,41,39,39)	6.36 units on a scale Standard Error 0.124	6.10 units on a scale Standard Error 0.180	6.36 units on a scale Standard Error 0.163	6.23 units on a scale Standard Error 0.159	6.12 units on a scale Standard Error 0.118

SECONDARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 DAS28(CRP)	7.6 percentage of participants 0.110	14.6 percentage of participants 0.160	22.4 percentage of participants 0.139	18.8 percentage of participants 0.146	23.4 percentage of participants 0.115
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 DAS28(ESR)	3.3 percentage of participants 0.120	6.3 percentage of participants 0.166	8.2 percentage of participants 0.163	8.3 percentage of participants 0.162	6.4 percentage of participants 0.165

SECONDARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region European: DAS28(CRP):(n=75,39,41,39,39)	6.7 percentage of participants 0.110	15.4 percentage of participants 0.160	17.1 percentage of participants 0.139	17.9 percentage of participants 0.146	23.1 percentage of participants 0.115
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region European: DAS28(ESR):(n=75,39,41,39,39)	1.3 percentage of participants 0.120	7.7 percentage of participants 0.166	9.8 percentage of participants 0.163	7.7 percentage of participants 0.162	7.7 percentage of participants 0.165
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region Japanese: DAS28(CRP) (n=17,9,8,9,8)	11.8 percentage of participants	11.1 percentage of participants	50.0 percentage of participants	22.2 percentage of participants	25.0 percentage of participants
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region Japanese: DAS28(ESR) (n=17,9,8,9,8)	11.8 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	11.1 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Day 169 (follow-up)

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission DAS28 (CRP) Response	88.0 days 95% Confidence Interval 0.110 • Interval 57.0 to 88.0	84.0 days 95% Confidence Interval 0.160 • Interval 43.0 to Upper limit of CI was not estimable since low number of participants achieved response in this arm.	43.0 days 95% Confidence Interval 0.139 • Interval 29.0 to 58.0	71.0 days 95% Confidence Interval 0.146 • Interval 42.0 to 89.0	42.0 days 95% Confidence Interval 0.115 • Interval 29.0 to 45.0
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission DAS28 (CRP) Remission	NA days 95% Confidence Interval 0.120 Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days 95% Confidence Interval 0.166 Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days 95% Confidence Interval 0.163 Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days 95% Confidence Interval 0.162 Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days 95% Confidence Interval 0.165 Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission DAS28 (ESR) Response	85.0 days Interval 57.0 to 88.0	58.0 days Interval 43.0 to 86.0	30.0 days Interval 29.0 to 43.0	57.0 days Interval 29.0 to 71.0	29.0 days Interval 28.0 to 42.0
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission DAS28 (ESR) Remission	NA days Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.	NA days Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.

SECONDARY outcome

Timeframe: Baseline up to Day 169 (follow-up)

DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region Japanese: DAS28 (CRP) Response (n=17,9,8,9,8)	NA days 95% Confidence Interval 0.120 Median and 95% CI were not estimable since less than 50% of the participants achieved response in this group.	NA days 95% Confidence Interval 0.166 Median and 95% CI were not estimable since less than 50% of the participants achieved response in this group.	22.5 days 95% Confidence Interval 0.163 • Interval 15.0 to 57.0	87.0 days 95% Confidence Interval 0.162 • Interval 30.0 to 87.0	37.0 days 95% Confidence Interval 0.165 • Interval 15.0 to 57.0
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region European: DAS28 (ESR) Response (n=75,39,41,39,39)	71.0 days Interval 57.0 to 88.0	57.0 days Interval 30.0 to 85.0	42.0 days Interval 29.0 to 43.0	52.5 days Interval 29.0 to 84.0	29.0 days Interval 28.0 to 42.0
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region European: DAS28 (CRP) Response (n=75,39,41,39,39)	85.0 days 95% Confidence Interval 0.110 • Interval 57.0 to 88.0	43.0 days 95% Confidence Interval 0.160 • Interval 43.0 to Upper limit of CI was not estimable since low number of participants achieved response in this arm.	43.0 days 95% Confidence Interval 0.139 • Interval 42.0 to 71.0	50.0 days 95% Confidence Interval 0.146 • Interval 29.0 to 89.0	42.0 days 95% Confidence Interval 0.115 • Interval 29.0 to 57.0
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region Japanese: DAS28 (ESR) Response (n=17,9,8,9,8)	NA days Median and 95% CI were not estimable since less than 50% of the participants achieved response in this group.	86.0 days Interval 57.0 to 86.0	29.0 days Interval 15.0 to 44.0	44.5 days Interval 29.0 to Upper limit of CI was not estimable since low number of participants achieved response in this arm.	30.0 days Interval 15.0 to 44.0

SECONDARY outcome

Timeframe: Baseline up to Day 169

DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Expected duration of response (DOR) was calculated as response rate (in percentage) multiplied by mean DOR (in days) by using Weibull Model. Duration of DAS28 (CRP) and DAS28 (ESR) remission were not analyzed because very few participants achieved remission in the overall study population.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission DAS28 (CRP) Response	43.40 Percentage of days 0.110 • Interval 0.61 to 1.55	42.19 Percentage of days 0.160 • Interval 43.0 to	81.89 Percentage of days 0.139 • Interval 29.0 to 58.0	54.80 Percentage of days 0.146 • Interval 42.0 to 89.0	83.07 Percentage of days 0.115 • Interval 29.0 to 45.0
Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission DAS28 (ESR) Response	46.11 Percentage of days 0.120	52.96 Percentage of days 0.166	71.14 Percentage of days 0.163	75.97 Percentage of days 0.162	96.52 Percentage of days 0.165

SECONDARY outcome

Timeframe: Day 85

ACR20, ACR50, and ACR70, were defined as greater than or equal to (\>=) 20 percent (%),\>=50%, or \>=70% improvement, respectively, in: swollen joint count and tender joint count and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 ACR50	12.0 percentage of participants 0.120	20.8 percentage of participants 0.166	30.6 percentage of participants 0.163	16.7 percentage of participants 0.162	34.0 percentage of participants 0.165
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 ACR20	37.0 percentage of participants 0.110 • Interval 57.0 to 88.0	41.7 percentage of participants 0.160 • Interval 43.0 to	57.1 percentage of participants 0.139 • Interval 29.0 to 58.0	37.5 percentage of participants 0.146 • Interval 42.0 to 89.0	70.2 percentage of participants 0.115 • Interval 29.0 to 45.0
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 ACR70	5.4 percentage of participants Interval 57.0 to 88.0	4.2 percentage of participants Interval 43.0 to 86.0	10.2 percentage of participants Interval 29.0 to 43.0	6.3 percentage of participants Interval 29.0 to 71.0	14.9 percentage of participants Interval 28.0 to 42.0

SECONDARY outcome

Timeframe: Day 85

ACR20, ACR50, and ACR70, were defined as \>=20%, \>=50%, or \>=70% improvement, respectively, in: SJC and TJC and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Data for the European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region Japanese: ACR20 (n=17,9,8,9,8)	23.5 percentage of participants 0.120	44.4 percentage of participants 0.166	62.5 percentage of participants 0.163	22.2 percentage of participants 0.162	75.0 percentage of participants 0.165
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region European: ACR70 (n=75,39,41,39,39)	4.0 percentage of participants	5.1 percentage of participants	9.8 percentage of participants	7.7 percentage of participants	17.9 percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region Japanese: ACR70 (n=17,9,8,9,8)	11.8 percentage of participants	0.0 percentage of participants	12.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region European: ACR20 (n=75,39,41,39,39)	40.0 percentage of participants 0.110 • Interval 57.0 to 88.0	41.0 percentage of participants 0.160 • Interval 43.0 to	56.1 percentage of participants 0.139 • Interval 29.0 to 58.0	41.0 percentage of participants 0.146 • Interval 42.0 to 89.0	69.2 percentage of participants 0.115 • Interval 29.0 to 45.0
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region European: ACR50 (n=75,39,41,39,39)	12.0 percentage of participants Interval 57.0 to 88.0	23.1 percentage of participants Interval 43.0 to 86.0	29.3 percentage of participants Interval 29.0 to 43.0	20.5 percentage of participants Interval 29.0 to 71.0	30.8 percentage of participants Interval 28.0 to 42.0
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region Japanese: ACR50 (n=17,9,8,9,8)	11.8 percentage of participants	11.1 percentage of participants	37.5 percentage of participants	0.0 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: Day 85

ACR20, ACR50, and ACR70, were defined as \>=20%, \>=50%, or \>=70% improvement, respectively, in: SJC and TJC and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. ACR responses were categorized as "No response", "ACR20 but not ACR50", "ACR50 but not ACR70", and "ACR70".

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Number of Participants Who Achieved ACR Categorical Responses No response	58 participants 0.110 • Interval 57.0 to 88.0	28 participants 0.160 • Interval 43.0 to	21 participants 0.139 • Interval 29.0 to 58.0	30 participants 0.146 • Interval 42.0 to 89.0	14 participants 0.115 • Interval 29.0 to 45.0
Number of Participants Who Achieved ACR Categorical Responses ACR20 but not ACR50	23 participants 0.120	10 participants 0.166	13 participants 0.163	10 participants 0.162	17 participants 0.165
Number of Participants Who Achieved ACR Categorical Responses ACR50 but not ACR70	6 participants Interval 57.0 to 88.0	8 participants Interval 43.0 to 86.0	10 participants Interval 29.0 to 43.0	5 participants Interval 29.0 to 71.0	9 participants Interval 28.0 to 42.0
Number of Participants Who Achieved ACR Categorical Responses ACR70	5 participants	2 participants	5 participants	3 participants	7 participants

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=44 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=45 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Continuous ACR (ACRn) Score	5.09 units on a scale Standard Error 4.230 • Interval 57.0 to 88.0	19.13 units on a scale Standard Error 5.818 • Interval 43.0 to	26.31 units on a scale Standard Error 5.652 • Interval 29.0 to 58.0	12.17 units on a scale Standard Error 5.786 • Interval 42.0 to 89.0	37.11 units on a scale Standard Error 5.723 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for this measure for the specified region for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=44 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=45 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Continuous ACR (ACRn) Score by Region European region (n=69,36,39,38,38)	4.71 units on a scale Standard Error 4.689 • Interval 57.0 to 88.0	19.18 units on a scale Standard Error 6.489 • Interval 43.0 to	24.12 units on a scale Standard Error 6.263 • Interval 29.0 to 58.0	12.53 units on a scale Standard Error 6.356 • Interval 42.0 to 89.0	36.06 units on a scale Standard Error 6.356 • Interval 29.0 to 45.0
Continuous ACR (ACRn) Score by Region Japanese region (n=15,8,8,7,8)	5.99 units on a scale Standard Error 10.060	18.09 units on a scale Standard Error 13.843	37.22 units on a scale Standard Error 13.843	10.20 units on a scale Standard Error 14.799	42.09 units on a scale Standard Error 13.843

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Swollen and Tender Joint Count Swollen joint count	9.2 joints Standard Deviation 10.0 • Interval 57.0 to 88.0	8.0 joints Standard Deviation 8.4 • Interval 43.0 to	5.4 joints Standard Deviation 6.8 • Interval 29.0 to 58.0	5.8 joints Standard Deviation 7.4 • Interval 42.0 to 89.0	4.4 joints Standard Deviation 4.3 • Interval 29.0 to 45.0
Swollen and Tender Joint Count Tender joint count	14.8 joints Standard Deviation 13.1	11.2 joints Standard Deviation 10.9	9.8 joints Standard Deviation 10.1	13.9 joints Standard Deviation 11.8	9.1 joints Standard Deviation 8.8

SECONDARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Swollen and Tender Joint Count by Region European: Swollen joint count (n=69,36,39,39,38)	9.6 joints Standard Deviation 10.4 • Interval 57.0 to 88.0	8.0 joints Standard Deviation 8.2 • Interval 43.0 to	5.6 joints Standard Deviation 7.2 • Interval 29.0 to 58.0	6.4 joints Standard Deviation 8.0 • Interval 42.0 to 89.0	4.2 joints Standard Deviation 4.4 • Interval 29.0 to 45.0
Swollen and Tender Joint Count by Region Japanese: Swollen joint count (n=16,9,8,9,8)	7.6 joints Standard Deviation 8.0	7.8 joints Standard Deviation 9.5	4.6 joints Standard Deviation 4.1	3.1 joints Standard Deviation 2.9	4.9 joints Standard Deviation 4.3
Swollen and Tender Joint Count by Region European: Tender joint count (n=69,36,39,39,38)	15.9 joints Standard Deviation 13.1 • Interval 57.0 to 88.0	11.0 joints Standard Deviation 11.4 • Interval 43.0 to 86.0	11.2 joints Standard Deviation 10.5 • Interval 29.0 to 43.0	14.8 joints Standard Deviation 12.0 • Interval 29.0 to 71.0	9.9 joints Standard Deviation 9.0 • Interval 28.0 to 42.0
Swollen and Tender Joint Count by Region Japanese: Tender joint count (n=16,9,8,9,8)	9.6 joints Standard Deviation 11.9	12.1 joints Standard Deviation 9.1	2.8 joints Standard Deviation 2.4	9.6 joints Standard Deviation 10.1	5.5 joints Standard Deviation 7.2

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Physician Global Assessment of Arthritis was measured on a 0 to 10 centimeter (cm) Visual Analogue Scale (VAS), where 0 cm = very good and 10 cm = very bad.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Physician Global Assessment of Disease Activity Score	3.82 cm Standard Deviation 2.05 • Interval 57.0 to 88.0	3.30 cm Standard Deviation 2.16 • Interval 43.0 to	3.13 cm Standard Deviation 1.80 • Interval 29.0 to 58.0	3.45 cm Standard Deviation 1.97 • Interval 42.0 to 89.0	2.95 cm Standard Deviation 1.70 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. Data for European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Physician Global Assessment of Disease Activity Score by Region European region (n=69,36,39,39,38)	3.93 cm Standard Deviation 2.06 • Interval 57.0 to 88.0	3.29 cm Standard Deviation 2.21 • Interval 43.0 to	3.20 cm Standard Deviation 1.79 • Interval 29.0 to 58.0	3.54 cm Standard Deviation 1.98 • Interval 42.0 to 89.0	3.12 cm Standard Deviation 1.74 • Interval 29.0 to 45.0
Physician Global Assessment of Disease Activity Score by Region Japanese region (n=16,9,8,9,8)	3.31 cm Standard Deviation 1.99	3.37 cm Standard Deviation 2.05	2.79 cm Standard Deviation 1.91	3.08 cm Standard Deviation 2.03	2.18 cm Standard Deviation 1.37

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Patient Global Assessment of Disease Activity Score	45.1 mm Standard Deviation 24.2 • Interval 57.0 to 88.0	40.0 mm Standard Deviation 22.8 • Interval 43.0 to	37.2 mm Standard Deviation 21.1 • Interval 29.0 to 58.0	41.1 mm Standard Deviation 23.2 • Interval 42.0 to 89.0	35.5 mm Standard Deviation 19.3 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly. Data for European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Patient Global Assessment of Disease Activity Score by Region European region (n=69,36,39,39,38)	45.9 mm Standard Deviation 23.8 • Interval 57.0 to 88.0	39.5 mm Standard Deviation 22.2 • Interval 43.0 to	39.0 mm Standard Deviation 20.6 • Interval 29.0 to 58.0	42.5 mm Standard Deviation 23.6 • Interval 42.0 to 89.0	37.3 mm Standard Deviation 19.2 • Interval 29.0 to 45.0
Patient Global Assessment of Disease Activity Score by Region Japanese region (n=16,9,8,9,8)	41.5 mm Standard Deviation 26.2	41.9 mm Standard Deviation 26.5	28.8 mm Standard Deviation 22.7	35.0 mm Standard Deviation 21.4	26.9 mm Standard Deviation 18.7

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Patient Pain Assessment Score	44.5 mm Standard Deviation 24.9 • Interval 57.0 to 88.0	38.7 mm Standard Deviation 24.1 • Interval 43.0 to	38.1 mm Standard Deviation 24.2 • Interval 29.0 to 58.0	40.1 mm Standard Deviation 24.2 • Interval 42.0 to 89.0	34.4 mm Standard Deviation 21.6 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. Data for European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Patient Pain Assessment Score by Region Japanese region (n=16,9,8,9,8)	42.6 mm Standard Deviation 27.8	41.1 mm Standard Deviation 25.5	33.3 mm Standard Deviation 26.1	34.1 mm Standard Deviation 23.6	27.0 mm Standard Deviation 19.4
Patient Pain Assessment Score by Region European region (n=69,36,39,39,38)	44.9 mm Standard Deviation 24.4 • Interval 57.0 to 88.0	38.1 mm Standard Deviation 24.1 • Interval 43.0 to	39.1 mm Standard Deviation 24.0 • Interval 29.0 to 58.0	41.4 mm Standard Deviation 24.4 • Interval 42.0 to 89.0	36.0 mm Standard Deviation 22.0 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Health Assessments Questionnaire-Disability Index (HAQ-DI) Score	1.19 units on a scale Standard Deviation 0.68 • Interval 57.0 to 88.0	1.02 units on a scale Standard Deviation 0.51 • Interval 43.0 to	1.02 units on a scale Standard Deviation 0.64 • Interval 29.0 to 58.0	1.10 units on a scale Standard Deviation 0.61 • Interval 42.0 to 89.0	0.95 units on a scale Standard Deviation 0.59 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region European region (n=69,36,39,39,38)	1.22 units on a scale Standard Deviation 0.65 • Interval 57.0 to 88.0	1.10 units on a scale Standard Deviation 0.47 • Interval 43.0 to	1.05 units on a scale Standard Deviation 0.67 • Interval 29.0 to 58.0	1.16 units on a scale Standard Deviation 0.63 • Interval 42.0 to 89.0	1.03 units on a scale Standard Deviation 0.56 • Interval 29.0 to 45.0
Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region Japanese region (n=16,9,8,9,8)	1.09 units on a scale Standard Deviation 0.82	0.72 units on a scale Standard Deviation 0.61	0.91 units on a scale Standard Deviation 0.53	0.82 units on a scale Standard Deviation 0.44	0.56 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Health Assessments Questionnaire (HAQ) Pain Score	46.3 units on a scale Standard Deviation 24.3 • Interval 57.0 to 88.0	40.9 units on a scale Standard Deviation 23.5 • Interval 43.0 to	39.0 units on a scale Standard Deviation 25.0 • Interval 29.0 to 58.0	42.6 units on a scale Standard Deviation 23.5 • Interval 42.0 to 89.0	35.0 units on a scale Standard Deviation 20.8 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. Data for European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Health Assessments Questionnaire (HAQ) Pain Score by Region European region (n=69,36,39,39,38)	47.0 units on a scale Standard Deviation 23.9 • Interval 57.0 to 88.0	40.3 units on a scale Standard Deviation 23.6 • Interval 43.0 to	40.6 units on a scale Standard Deviation 24.8 • Interval 29.0 to 58.0	43.8 units on a scale Standard Deviation 23.8 • Interval 42.0 to 89.0	36.5 units on a scale Standard Deviation 21.1 • Interval 29.0 to 45.0
Health Assessments Questionnaire (HAQ) Pain Score by Region Japanese region (n=16,9,8,9,8)	43.1 units on a scale Standard Deviation 26.3	43.1 units on a scale Standard Deviation 24.5	31.0 units on a scale Standard Deviation 26.1	37.3 units on a scale Standard Deviation 22.9	28.3 units on a scale Standard Deviation 19.1

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=46 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Serum Concentration of C-Reactive Protein (CRP)	11.49 mg/L Standard Deviation 4.67 • Interval 57.0 to 88.0	9.62 mg/L Standard Deviation 4.15 • Interval 43.0 to	9.35 mg/L Standard Deviation 3.92 • Interval 29.0 to 58.0	5.71 mg/L Standard Deviation 2.97 • Interval 42.0 to 89.0	6.12 mg/L Standard Deviation 2.90 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=46 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Serum Concentration of C-Reactive Protein (CRP) by Region European region (n=69,36,38,39,38)	11.89 mg/L Standard Deviation 18.57 • Interval 57.0 to 88.0	8.86 mg/L Standard Deviation 13.10 • Interval 43.0 to	10.24 mg/L Standard Deviation 16.68 • Interval 29.0 to 58.0	6.50 mg/L Standard Deviation 7.60 • Interval 42.0 to 89.0	5.84 mg/L Standard Deviation 9.68 • Interval 29.0 to 45.0
Serum Concentration of C-Reactive Protein (CRP) by Region Japanese region (n=16,9,8,9,8)	9.75 mg/L Standard Deviation 11.93	12.67 mg/L Standard Deviation 18.47	5.13 mg/L Standard Deviation 6.83	2.28 mg/L Standard Deviation 1.92	7.44 mg/L Standard Deviation 12.26

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Serum Concentration of Erythrocyte Sedimentation Rate (ESR)	34.4 mm/hr Standard Deviation 26.5 • Interval 57.0 to 88.0	31.3 mm/hr Standard Deviation 19.0 • Interval 43.0 to	34.1 mm/hr Standard Deviation 23.6 • Interval 29.0 to 58.0	29.7 mm/hr Standard Deviation 19.1 • Interval 42.0 to 89.0	23.6 mm/hr Standard Deviation 14.6 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Data for European and Japanese regions were reported.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=47 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region Japanese region (n=16,9,8,9,8)	36.6 mm/hr Standard Deviation 20.8	35.0 mm/hr Standard Deviation 22.5	38.8 mm/hr Standard Deviation 22.6	16.3 mm/hr Standard Deviation 13.6	25.9 mm/hr Standard Deviation 16.7
Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region European region (n=69,36,39,39,38)	33.9 mm/hr Standard Deviation 27.8 • Interval 57.0 to 88.0	30.3 mm/hr Standard Deviation 18.3 • Interval 43.0 to	33.2 mm/hr Standard Deviation 23.9 • Interval 29.0 to 58.0	32.7 mm/hr Standard Deviation 19.0 • Interval 42.0 to 89.0	23.1 mm/hr Standard Deviation 14.3 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=46 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=46 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Serum Concentration of Rheumatoid Factor (RF)	109.82 units per milliliter Standard Deviation 135.39 • Interval 57.0 to 88.0	79.62 units per milliliter Standard Deviation 93.21 • Interval 43.0 to	177.84 units per milliliter Standard Deviation 352.16 • Interval 29.0 to 58.0	85.15 units per milliliter Standard Deviation 81.47 • Interval 42.0 to 89.0	83.26 units per milliliter Standard Deviation 118.14 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Day 85

Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=45 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=46 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=45 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA)	295.90 units per milliliter Standard Deviation 920.92 • Interval 57.0 to 88.0	232.22 units per milliliter Standard Deviation 469.86 • Interval 43.0 to	211.77 units per milliliter Standard Deviation 250.50 • Interval 29.0 to 58.0	330.82 units per milliliter Standard Deviation 549.05 • Interval 42.0 to 89.0	221.18 units per milliliter Standard Deviation 333.28 • Interval 29.0 to 45.0

SECONDARY outcome

Timeframe: Baseline up to Day 169

Additional medication included concomitant medication (medication used for purposes other than managing rheumatoid arthritis \[RA\]) and RA medication (for managing RA). Number of participants who used concomitant medication and RA medication was reported by anatomical therapeutic chemical (ATC) classification system.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 10 mg n=48 Participants Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 30 mg n=49 Participants Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 50 mg n=48 Participants Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.	Mavrilimumab 100 mg n=47 Participants Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Number of Participants Who Had Additional Medications Concomitant: Blood and blood forming agents	88 participants 0.110 • Interval 57.0 to 88.0	47 participants 0.160 • Interval 43.0 to	49 participants 0.139 • Interval 29.0 to 58.0	47 participants 0.146 • Interval 42.0 to 89.0	45 participants 0.115 • Interval 29.0 to 45.0
Number of Participants Who Had Additional Medications Concomitant: Alimentary tract and metabolism	45 participants 0.120	25 participants 0.166	25 participants 0.163	28 participants 0.162	23 participants 0.165
Number of Participants Who Had Additional Medications Concomitant: Cardiovascular system	30 participants Interval 57.0 to 88.0	20 participants Interval 43.0 to 86.0	19 participants Interval 29.0 to 43.0	12 participants Interval 29.0 to 71.0	22 participants Interval 28.0 to 42.0
Number of Participants Who Had Additional Medications Concomitant: Nervous system	14 participants	9 participants	9 participants	6 participants	3 participants
Number of Participants Who Had Additional Medications Concomitant: Musculo-skeletal system	11 participants	9 participants	5 participants	8 participants	5 participants
Number of Participants Who Had Additional Medications Concomitant: Respiratory system	11 participants	6 participants	7 participants	5 participants	5 participants
Number of Participants Who Had Additional Medications Concomitant: Anti-infective for systemic use	10 participants	6 participants	6 participants	8 participants	2 participants
Number of Participants Who Had Additional Medications Concomitant:Genito-urinary system and sex hormones	4 participants	6 participants	6 participants	4 participants	4 participants
Number of Participants Who Had Additional Medications Concomitant: Systemic hormonal preps	8 participants	5 participants	4 participants	2 participants	0 participants
Number of Participants Who Had Additional Medications Concomitant: Various	6 participants	5 participants	2 participants	2 participants	4 participants
Number of Participants Who Had Additional Medications Concomitant: Dermatologicals	2 participants	1 participants	5 participants	2 participants	2 participants
Number of Participants Who Had Additional Medications Concomitant: Sensory organs	0 participants	2 participants	3 participants	2 participants	2 participants
Number of Participants Who Had Additional Medications Concomitant: Anti-parasitic products	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Who Had Additional Medications RA: Antineoplastic and immunomodulating agents	92 participants	48 participants	49 participants	48 participants	47 participants
Number of Participants Who Had Additional Medications RA: Musculo-skeletal system	65 participants	35 participants	38 participants	32 participants	31 participants
Number of Participants Who Had Additional Medications RA: Systemic hormonal preps	47 participants	23 participants	21 participants	21 participants	23 participants
Number of Participants Who Had Additional Medications RA: Nervous system	4 participants	0 participants	2 participants	2 participants	1 participants
Number of Participants Who Had Additional Medications RA: Alimentary tract and metabolism	0 participants	2 participants	0 participants	1 participants	0 participants
Number of Participants Who Had Additional Medications RA: Dermatologicals	1 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants Who Had Additional Medications RA: Respiratory system	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants Who Had Additional Medications RA: Sensory organs	0 participants	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Day 1 to 85, Day 86 to 169

Participants received MTX at stable and tolerated dose during baseline were categorized as "low dose (\<12.5 mg per week \[mg/wk\])", "medium dose (\>=12.5 - \<20 mg/wk)", and "high dose (\>=20 mg/wk)". Participants received oral CST at stable dose during baseline were categorized as "low dose (\<5 mg/day)", and "high dose (\>=5 mg/day)". Change in MTX and CST dose from baseline between Day 1-85 and Day 86-169 were categorized as follows: 'Increased', 'no change' and 'decreased'. Participants were counted once with dose increases counted first, followed by no change and then dose decreases.