A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01706926

Enrollment

420

Registered

2012-10-15

Start date

2012-08-31

Completion date

2014-01-31

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Mavrilimumab, CAM-3001

Brief summary

The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Detailed description

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.

Interventions

BIOLOGICALMavrilimumab 30 mg

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks

BIOLOGICALMavrilimumab 100 mg

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.

BIOLOGICALMavrilimumab 150 mg

Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.

OTHERPlacebo

Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* A diagnosis of adult onset Rheumatoid Arthritis (RA) in line with the protocol * Moderately active disease in line with the protocol * A pre-defined number of swollen joints in line with the protocol * Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) * No evidence of respiratory disease.

Exclusion criteria

* A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA * A history of, or current, inflammatory joint disease other than RA * Previous treatment with the investigational drug * Discontinuation of a biologic DMARD due to lack of efficacy * Non-compliant concurrent medications * Non-compliance with medical history criteria.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Baseline and Day 85	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.
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	Day 169	ACR20 was defined as \>=20 percent (%) improvement, in: SJC and TJC and \>=20% improvement 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 CRP.

Secondary

Measure	Time frame	Description
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Baseline up to Day 169	Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	Day 169	Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six 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. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=\<) 15 percent (%), more than (\>) 15 to =\<20%, and \>20%.
Dyspnea Score at Day 169	Day 169	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.
Oxygen Saturation Level at Day 169	Day 169	Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169	Day 169	ACR50 was defined as \>=50% improvement, in: SJC and TJC and \>=50% improvement 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.
Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169	Day 169	ACR70 was defined as \>=70% improvement, in: SJC and TJC and \>=70% improvement 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.
Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169	Baseline up to Day 169	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.
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Day 169	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.
Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	Day 169	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. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.
Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	Baseline and Day 169	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.
Mean Change From Baseline in Patient Assessment of Pain at Day 169	Baseline and Day 169	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	Baseline up to Day 169	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 Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Baseline and Day 169	Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Baseline and Day 169	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 was 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 from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.
Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169	Baseline, Day 169	CRP is a substance produced by the liver that increases in the presence of inflammation in the body. 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 in underlying disease.
Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169	Baseline, Day 169	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. The farther the red blood cells have descended, the greater the inflammatory response.
Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169	Day 169	The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter \[mg/dL\]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.
Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169	Day 169	The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.
Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169	Day 169	ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Baseline and Day 169	FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.
Serum Concentrations of Mavrilimumab	Baseline, Day 8, 15, 29, 85, 141, and 169	Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.
Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit	Day 1 to Day 169	Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.
Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Baseline and Day 169	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.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Baseline up to Day 169	Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.

Countries

Argentina, Bulgaria, Chile, Colombia, Czechia, Estonia, Germany, Hungary, Poland, Russia, Serbia, South Africa, Spain, Ukraine

Participant flow

Pre-assignment details

A total of 420 participants were screened out of which 326 participants were randomized and received investigational product in the study.

Participants by arm

Arm	Count
Placebo Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram \[mg\] per week) through oral or parenteral route.	81
Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.	81
Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.	85
Mavrilimumab 150 mg Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.	79
Total	326

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	0	0	1	0
Overall Study	Other	4	4	4	3
Overall Study	Withdrawal by Subject	2	0	1	2

Baseline characteristics

Characteristic	Placebo	Mavrilimumab 30 mg	Mavrilimumab 100 mg	Mavrilimumab 150 mg	Total
Age, Continuous	52.8 years STANDARD_DEVIATION 10.6	51.2 years STANDARD_DEVIATION 11.6	50.8 years STANDARD_DEVIATION 11.9	52.6 years STANDARD_DEVIATION 10.3	51.8 years STANDARD_DEVIATION 11.1
Sex: Female, Male Female	75 Participants	70 Participants	70 Participants	67 Participants	282 Participants
Sex: Female, Male Male	6 Participants	11 Participants	15 Participants	12 Participants	44 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	38 / 81	41 / 81	36 / 85	43 / 79
serious Total, serious adverse events	1 / 81	4 / 81	5 / 85	2 / 79

Outcome results

Primary

Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85

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.

Time frame: Baseline and Day 85

Population: The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Baseline (n=81, 81, 85, 79)	5.78 units on a scale	Standard Error 0.09
Placebo	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Change at Day 85 (n=77, 76, 79, 78)	-0.68 units on a scale	Standard Error 0.136
Mavrilimumab 30 mg	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Change at Day 85 (n=77, 76, 79, 78)	-1.37 units on a scale	Standard Error 0.136
Mavrilimumab 30 mg	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Baseline (n=81, 81, 85, 79)	5.73 units on a scale	Standard Error 0.104
Mavrilimumab 100 mg	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Change at Day 85 (n=77, 76, 79, 78)	-1.64 units on a scale	Standard Error 0.132
Mavrilimumab 100 mg	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Baseline (n=81, 81, 85, 79)	5.91 units on a scale	Standard Error 0.096
Mavrilimumab 150 mg	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Change at Day 85 (n=77, 76, 79, 78)	-1.90 units on a scale	Standard Error 0.136
Mavrilimumab 150 mg	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Baseline (n=81, 81, 85, 79)	5.67 units on a scale	Standard Error 0.086

Comparison: Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.p-value: <0.00195% CI: [-1.06, -0.31]Repeated measures model

Comparison: Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.p-value: <0.00195% CI: [-1.33, -0.58]Repeated measures model

Primary

Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169

ACR20 was defined as \>=20 percent (%) improvement, in: SJC and TJC and \>=20% improvement 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 CRP.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	24.7 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	50.6 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	61.2 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	73.4 percentage of participants

p-value: <0.00195% CI: [11.5, 40.3]Regression, Logistic

p-value: <0.00195% CI: [22.5, 50.5]Regression, Logistic

p-value: <0.00195% CI: [35.2, 62.3]Regression, Logistic

Secondary

Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169

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.

Time frame: Baseline up to Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169	13.25 units on a scale	Standard Error 4.63
Mavrilimumab 30 mg	Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169	29.04 units on a scale	Standard Error 3.828
Mavrilimumab 100 mg	Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169	30.24 units on a scale	Standard Error 3.623
Mavrilimumab 150 mg	Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169	40.72 units on a scale	Standard Error 3.644

p-value: 0.00995% CI: [3.96, 27.61]Repeated measures model

p-value: 0.00495% CI: [5.42, 28.56]Repeated measures model

p-value: <0.00195% CI: [15.87, 39.07]Repeated measures model

Secondary

Dyspnea Score at Day 169

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.

Time frame: Day 169

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.

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Dyspnea Score at Day 169	0.38 units on a scale	Standard Deviation 0.62
Mavrilimumab 30 mg	Dyspnea Score at Day 169	0.22 units on a scale	Standard Deviation 0.54
Mavrilimumab 100 mg	Dyspnea Score at Day 169	0.32 units on a scale	Standard Deviation 0.73
Mavrilimumab 150 mg	Dyspnea Score at Day 169	0.28 units on a scale	Standard Deviation 0.64

Secondary

Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169

FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.

Time frame: Baseline and Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Baseline (n=79, 80, 84, 79)	26.75 units on a scale	Standard Error 0.824
Placebo	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	4.53 units on a scale	Standard Error 1.225
Mavrilimumab 30 mg	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	5.72 units on a scale	Standard Error 1.039
Mavrilimumab 30 mg	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Baseline (n=79, 80, 84, 79)	28.91 units on a scale	Standard Error 1.078
Mavrilimumab 100 mg	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Baseline (n=79, 80, 84, 79)	28.45 units on a scale	Standard Error 0.998
Mavrilimumab 100 mg	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	6.80 units on a scale	Standard Error 0.988
Mavrilimumab 150 mg	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Baseline (n=79, 80, 84, 79)	27.82 units on a scale	Standard Error 0.95
Mavrilimumab 150 mg	Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	8.45 units on a scale	Standard Error 0.997

p-value: 0.46395% CI: [-1.99, 4.35]Repeated measures model

p-value: 0.15195% CI: [-0.83, 5.37]Repeated measures model

p-value: 0.01495% CI: [0.81, 7.02]Repeated measures model

Secondary

Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169

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 was 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 from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Baseline (n=81, 80, 85, 79)	1.63 units on a scale	Standard Error 0.054
Placebo	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-0.29 units on a scale	Standard Error 0.081
Mavrilimumab 30 mg	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-0.37 units on a scale	Standard Error 0.072
Mavrilimumab 30 mg	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Baseline (n=81, 80, 85, 79)	1.52 units on a scale	Standard Error 0.07
Mavrilimumab 100 mg	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Baseline (n=81, 80, 85, 79)	1.58 units on a scale	Standard Error 0.056
Mavrilimumab 100 mg	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-0.46 units on a scale	Standard Error 0.068
Mavrilimumab 150 mg	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Baseline (n=81, 80, 85, 79)	1.58 units on a scale	Standard Error 0.059
Mavrilimumab 150 mg	Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-0.55 units on a scale	Standard Error 0.069

p-value: 0.47995% CI: [-0.29, 0.14]Repeated measures model

p-value: 0.12495% CI: [-0.37, 0.04]Repeated measures model

p-value: 0.01795% CI: [-0.47, -0.05]Repeated measures model

Secondary

Mean Change From Baseline in Patient Assessment of Pain at Day 169

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Baseline (n=81, 81, 85, 79)	62.16 mm	Standard Error 2.093
Placebo	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-15.20 mm	Standard Error 3.006
Mavrilimumab 30 mg	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-23.14 mm	Standard Error 2.563
Mavrilimumab 30 mg	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Baseline (n=81, 81, 85, 79)	62.65 mm	Standard Error 2.11
Mavrilimumab 100 mg	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Baseline (n=81, 81, 85, 79)	63.58 mm	Standard Error 2.034
Mavrilimumab 100 mg	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-23.31 mm	Standard Error 2.446
Mavrilimumab 150 mg	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Baseline (n=81, 81, 85, 79)	62.35 mm	Standard Error 2.217
Mavrilimumab 150 mg	Mean Change From Baseline in Patient Assessment of Pain at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-26.53 mm	Standard Error 2.483

p-value: 0.04595% CI: [-15.72, -0.17]Repeated measures model

p-value: 0.03795% CI: [-15.73, -0.48]Repeated measures model

p-value: 0.00495% CI: [-19, -3.65]Repeated measures model

Secondary

Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169

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.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Baseline (n=81, 81, 85, 79)	64.86 mm	Standard Error 1.892
Placebo	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-20.21 mm	Standard Error 3.148
Mavrilimumab 30 mg	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-21.06 mm	Standard Error 2.685
Mavrilimumab 30 mg	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Baseline (n=81, 81, 85, 79)	63.79 mm	Standard Error 2.074
Mavrilimumab 100 mg	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Baseline (n=81, 81, 85, 79)	63.71 mm	Standard Error 1.957
Mavrilimumab 100 mg	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-22.40 mm	Standard Error 2.56
Mavrilimumab 150 mg	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Baseline (n=81, 81, 85, 79)	62.39 mm	Standard Error 2.099
Mavrilimumab 150 mg	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-25.69 mm	Standard Error 2.6

p-value: 0.83795% CI: [-8.99, 7.29]Repeated measures model

p-value: 0.58995% CI: [-10.18, 5.79]Repeated measures model

p-value: 0.1895% CI: [-13.52, 2.55]Repeated measures model

Secondary

Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169

Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Baseline (n=81, 81, 85, 79)	6.60 cm	Standard Error 0.168
Placebo	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-2.39 cm	Standard Error 0.305
Mavrilimumab 30 mg	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-3.81 cm	Standard Error 0.254
Mavrilimumab 30 mg	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Baseline (n=81, 81, 85, 79)	6.60 cm	Standard Error 0.162
Mavrilimumab 100 mg	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-3.85 cm	Standard Error 0.241
Mavrilimumab 100 mg	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Baseline (n=81, 81, 85, 79)	6.81 cm	Standard Error 0.144
Mavrilimumab 150 mg	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Change at Day 169 (n=40, 65, 73, 74)	-3.95 cm	Standard Error 0.243
Mavrilimumab 150 mg	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169	Baseline (n=81, 81, 85, 79)	6.42 cm	Standard Error 0.166

p-value: <0.00195% CI: [-2.2, -0.63]Repeated measures model

p-value: <0.00195% CI: [-2.23, -0.69]Repeated measures model

p-value: <0.00195% CI: [-2.33, -0.79]Repeated measures model

Secondary

Mean Change From Baseline in Swollen and Tender Joint Count at Day 169

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.

Time frame: Baseline and Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Baseline (n=81,81,85,79)	14.44 joint count	Standard Error 0.765
Placebo	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Change at Day 169 (n=40,65,73,74)	-4.97 joint count	Standard Error 0.932
Placebo	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Baseline (n=81,81,85,79)	26.26 joint count	Standard Error 1.25
Placebo	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Change at Day 169 (n=40,65,73,74)	-7.90 joint count	Standard Error 1.447
Mavrilimumab 30 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Change at Day 169 (n=40,65,73,74)	-10.65 joint count	Standard Error 0.809
Mavrilimumab 30 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Baseline (n=81,81,85,79)	27.48 joint count	Standard Error 1.553
Mavrilimumab 30 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Change at Day 169 (n=40,65,73,74)	-15.14 joint count	Standard Error 1.265
Mavrilimumab 30 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Baseline (n=81,81,85,79)	17.80 joint count	Standard Error 1.126
Mavrilimumab 100 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Baseline (n=81,81,85,79)	26.96 joint count	Standard Error 1.544
Mavrilimumab 100 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Change at Day 169 (n=40,65,73,74)	-11.18 joint count	Standard Error 0.771
Mavrilimumab 100 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Change at Day 169 (n=40,65,73,74)	-16.35 joint count	Standard Error 1.207
Mavrilimumab 100 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Baseline (n=81,81,85,79)	16.82 joint count	Standard Error 0.93
Mavrilimumab 150 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Change at Day 169 (n=40,65,73,74)	-18.32 joint count	Standard Error 1.234
Mavrilimumab 150 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Change at Day 169 (n=40,65,73,74)	-11.96 joint count	Standard Error 0.787
Mavrilimumab 150 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	SJC: Baseline (n=81,81,85,79)	15.72 joint count	Standard Error 0.795
Mavrilimumab 150 mg	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169	TJC: Baseline (n=81,81,85,79)	26.70 joint count	Standard Error 1.284

Comparison: Analysis reported for change from baseline in swollen joint count at Day 169.p-value: <0.00195% CI: [-8.12, -3.24]Repeated measures model

Comparison: Analysis reported for change from baseline in swollen joint count at Day 169.p-value: <0.00195% CI: [-8.6, -3.82]Repeated measures model

Comparison: Analysis reported for change from baseline in swollen joint count at Day 169.p-value: <0.00195% CI: [-9.4, -4.59]Repeated measures model

Comparison: Analysis reported for change from baseline in tender joint count at Day 169.p-value: <0.00195% CI: [-11.02, -3.45]Repeated measures model

Comparison: Analysis reported for change from baseline in tender joint count at Day 169.p-value: <0.00195% CI: [-12.16, -4.74]Repeated measures model

Comparison: Analysis reported for change from baseline in tender joint count at Day 169.p-value: <0.00195% CI: [-14.17, -6.67]Repeated measures model

Secondary

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)

Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.

Time frame: Baseline up to Day 169

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

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Anemia	1 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Eosinophilia	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Leukocytosis	2 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Lymphopenia	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Neutropenia	1 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Alanine aminotransferase increased	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Aspartate aminotransferase increased	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Gamma-glutamyltransferase increased	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertransaminasaemia	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Dislipidaemia	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypercholesterolaemia	1 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperlipidaemia	0 participants
Placebo	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperkalaemia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Lymphopenia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperkalaemia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypercholesterolaemia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Gamma-glutamyltransferase increased	1 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Leukocytosis	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Anemia	1 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Dislipidaemia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertransaminasaemia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Alanine aminotransferase increased	1 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Neutropenia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Eosinophilia	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperlipidaemia	2 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Aspartate aminotransferase increased	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypercholesterolaemia	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Lymphopenia	0 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Neutropenia	0 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperkalaemia	0 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Alanine aminotransferase increased	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Aspartate aminotransferase increased	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperlipidaemia	0 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Gamma-glutamyltransferase increased	0 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertransaminasaemia	2 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Dislipidaemia	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Anemia	0 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Eosinophilia	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Leukocytosis	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Dislipidaemia	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Gamma-glutamyltransferase increased	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Lymphopenia	1 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Anemia	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Aspartate aminotransferase increased	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Alanine aminotransferase increased	1 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Leukocytosis	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Eosinophilia	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Neutropenia	3 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertransaminasaemia	2 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperkalaemia	1 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hyperlipidaemia	3 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypercholesterolaemia	0 participants

Secondary

Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

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

Time frame: Baseline up to Day 169

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

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertension	2 participants
Placebo	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Weight increased	1 participants
Placebo	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Pyrexia	0 participants
Placebo	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hot flush	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Weight increased	1 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hot flush	0 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertension	4 participants
Mavrilimumab 30 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Pyrexia	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Pyrexia	0 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hot flush	1 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertension	4 participants
Mavrilimumab 100 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Weight increased	1 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hot flush	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Hypertension	3 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Weight increased	0 participants
Mavrilimumab 150 mg	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	Pyrexia	0 participants

Secondary

Oxygen Saturation Level at Day 169

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

Time frame: Day 169

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Oxygen Saturation Level at Day 169	97.4 percent saturation	Standard Deviation 1.4
Mavrilimumab 30 mg	Oxygen Saturation Level at Day 169	97.4 percent saturation	Standard Deviation 1.1
Mavrilimumab 100 mg	Oxygen Saturation Level at Day 169	97.4 percent saturation	Standard Deviation 1.1
Mavrilimumab 150 mg	Oxygen Saturation Level at Day 169	97.3 percent saturation	Standard Deviation 1.2

Secondary

Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit

Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.

Time frame: Day 1 to Day 169

Population: The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit	2.5 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit	16.0 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit	3.5 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit	0.0 percentage of participants

Secondary

Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169

ACR50 was defined as \>=50% improvement, in: SJC and TJC and \>=50% improvement 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.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169	12.3 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169	28.4 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169	25.9 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169	40.5 percentage of participants

p-value: 0.01395% CI: [3.9, 28.2]Regression, Logistic

p-value: 0.0395% CI: [1.8, 25.3]Regression, Logistic

p-value: <0.00195% CI: [15.2, 41.1]Regression, Logistic

Secondary

Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169

ACR70 was defined as \>=70% improvement, in: SJC and TJC and \>=70% improvement 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.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169	3.7 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169	12.3 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169	10.6 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169	13.9 percentage of participants

p-value: 0.07995% CI: [0.4, 16.9]Fisher Exact

p-value: 0.13395% CI: [-0.8, 14.6]Fisher Exact

p-value: 0.02695% CI: [1.5, 18.9]Fisher Exact

Secondary

Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169

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.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Group	Value (NUMBER)	Dispersion
Placebo	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	No response	65.4 percentage of participants	0.09
Placebo	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Good response	8.6 percentage of participants	—
Placebo	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Moderate response	25.9 percentage of participants	0.136
Mavrilimumab 30 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	No response	30.9 percentage of participants	0.104
Mavrilimumab 30 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Good response	33.3 percentage of participants	—
Mavrilimumab 30 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Moderate response	35.8 percentage of participants	0.136
Mavrilimumab 100 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Moderate response	40.0 percentage of participants	0.132
Mavrilimumab 100 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	No response	28.2 percentage of participants	0.096
Mavrilimumab 100 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Good response	31.8 percentage of participants	—
Mavrilimumab 150 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	No response	19.0 percentage of participants	0.086
Mavrilimumab 150 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Good response	39.2 percentage of participants	—
Mavrilimumab 150 mg	Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169	Moderate response	41.8 percentage of participants	0.136

p-value: <0.00195% CI: [2.56, 8.8]Proportional odds analysis

p-value: <0.00195% CI: [2.64, 8.92]Proportional odds analysis

Secondary

Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169

ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Value (NUMBER)	Dispersion
Placebo	Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169	0.0 percentage of participants	0.054
Mavrilimumab 30 mg	Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169	3.7 percentage of participants	0.07
Mavrilimumab 100 mg	Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169	1.2 percentage of participants	0.056
Mavrilimumab 150 mg	Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169	1.3 percentage of participants	0.059

p-value: 0.24595% CI: [-0.4, 7.8]Fisher Exact

p-value: 195% CI: [-1.1, 3.5]Fisher Exact

p-value: 0.49495% CI: [-1.2, 3.7]Fisher Exact

Secondary

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169

The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Value (NUMBER)	Dispersion
Placebo	Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169	1.2 percentage of participants	0.054
Mavrilimumab 30 mg	Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169	6.2 percentage of participants	0.07
Mavrilimumab 100 mg	Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169	3.5 percentage of participants	0.056
Mavrilimumab 150 mg	Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169	7.6 percentage of participants	0.059

p-value: 0.2195% CI: [-0.8, 10.7]Fisher Exact

p-value: 0.62195% CI: [-2.3, 6.9]Fisher Exact

p-value: 0.06295% CI: [0, 12.7]Fisher Exact

Secondary

Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169

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. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	DAS28 (CRP) Remission	4.9 percentage of participants
Placebo	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	Low Disease Activity	8.6 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	Low Disease Activity	33.3 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	DAS28 (CRP) Remission	21.0 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	DAS28 (CRP) Remission	17.6 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	Low Disease Activity	31.8 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	DAS28 (CRP) Remission	19.0 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169	Low Disease Activity	41.8 percentage of participants

Comparison: The analysis reported DAS28 (CRP) low disease activity response.p-value: <0.00195% CI: [20.7, 45.6]Regression, Logistic

Comparison: DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.p-value: 0.00495% CI: [6, 26.1]Fisher Exact

Comparison: DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.p-value: 0.01495% CI: [3.3, 22.1]Fisher Exact

Comparison: DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.p-value: 0.00795% CI: [4.2, 23.9]Fisher Exact

Comparison: The analysis reported DAS28 (CRP) low disease activity response.p-value: <0.00195% CI: [12.7, 36.6]Regression, Logistic

Comparison: The analysis reported DAS28 (CRP) low disease activity response.p-value: <0.00195% CI: [11.5, 34.8]Regression, Logistic

Secondary

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169

The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter \[mg/dL\]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.

Time frame: Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Arm	Measure	Value (NUMBER)	Dispersion
Placebo	Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169	1.2 percentage of participants	0.054
Mavrilimumab 30 mg	Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169	6.2 percentage of participants	0.07
Mavrilimumab 100 mg	Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169	2.4 percentage of participants	0.056
Mavrilimumab 150 mg	Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169	5.1 percentage of participants	0.059

p-value: 0.2195% CI: [-0.8, 10.7]Fisher Exact

p-value: 195% CI: [-2.9, 5.1]Fisher Exact

p-value: 0.20795% CI: [-1.6, 9.2]Fisher Exact

Secondary

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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 Day 169 that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline up to Day 169

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

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TEAEs	46.9 percentage of participants
Placebo	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TESAEs	1.2 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TESAEs	4.9 percentage of participants
Mavrilimumab 30 mg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TEAEs	50.6 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TEAEs	42.4 percentage of participants
Mavrilimumab 100 mg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TESAEs	5.9 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TEAEs	54.4 percentage of participants
Mavrilimumab 150 mg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TESAEs	2.5 percentage of participants

Secondary

Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169

Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six 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. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=\<) 15 percent (%), more than (\>) 15 to =\<20%, and \>20%.

Time frame: Day 169

Population: The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC =<15% (n=42,67,75,75)	97.6 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >20% (n=41,66,71,68)	2.4 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >20% (n=42,67,75,75)	2.4 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 =<15% (n=41,66,71,68)	97.6 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >20% (n=42,67,75,75)	2.4 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >15 to 20% (n=42,67,75,75)	0.0 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >15 to 20% (n=42,67,75,75)	0.0 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >15 to 20% (n=41,66,71,68)	0.0 percent of pulmonary test values
Placebo	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 =<15% (n=42,67,75,75)	97.6 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >15 to 20% (n=41,66,71,68)	1.5 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC =<15% (n=42,67,75,75)	98.5 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >20% (n=41,66,71,68)	1.5 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >15 to 20% (n=42,67,75,75)	0.0 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 =<15% (n=42,67,75,75)	98.5 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >20% (n=42,67,75,75)	1.5 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >20% (n=42,67,75,75)	1.5 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >15 to 20% (n=42,67,75,75)	0.0 percent of pulmonary test values
Mavrilimumab 30 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 =<15% (n=41,66,71,68)	97.0 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >15 to 20% (n=41,66,71,68)	1.4 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 =<15% (n=42,67,75,75)	96.0 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >15 to 20% (n=42,67,75,75)	1.3 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >20% (n=42,67,75,75)	2.7 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 =<15% (n=41,66,71,68)	94.4 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >20% (n=41,66,71,68)	4.2 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC =<15% (n=42,67,75,75)	94.7 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >15 to 20% (n=42,67,75,75)	1.3 percent of pulmonary test values
Mavrilimumab 100 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >20% (n=42,67,75,75)	4.0 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC =<15% (n=42,67,75,75)	94.7 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 =<15% (n=41,66,71,68)	89.7 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >20% (n=42,67,75,75)	4.0 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >20% (n=42,67,75,75)	2.7 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FVC >15 to 20% (n=42,67,75,75)	2.7 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 >15 to 20% (n=42,67,75,75)	6.7 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >20% (n=41,66,71,68)	8.8 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV6 >15 to 20% (n=41,66,71,68)	1.5 percent of pulmonary test values
Mavrilimumab 150 mg	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	FEV1 =<15% (n=42,67,75,75)	89.3 percent of pulmonary test values

Secondary

Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169

CRP is a substance produced by the liver that increases in the presence of inflammation in the body. 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 in underlying disease.

Time frame: Baseline, Day 169

Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169	1.2971 ratio	Geometric Coefficient of Variation 83.3
Mavrilimumab 30 mg	Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169	0.8784 ratio	Geometric Coefficient of Variation 102.8
Mavrilimumab 100 mg	Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169	0.5197 ratio	Geometric Coefficient of Variation 287.4
Mavrilimumab 150 mg	Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169	0.5856 ratio	Geometric Coefficient of Variation 153.3

p-value: 0.01795% CI: [0.45, 0.92]Repeated measures model

p-value: <0.00195% CI: [0.32, 0.66]Repeated measures model

p-value: <0.00195% CI: [0.31, 0.63]Repeated measures model

Secondary

Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169

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. The farther the red blood cells have descended, the greater the inflammatory response.

Time frame: Baseline, Day 169

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169	0.89 ratio	Geometric Coefficient of Variation 57
Mavrilimumab 30 mg	Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169	0.67 ratio	Geometric Coefficient of Variation 56.4
Mavrilimumab 100 mg	Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169	0.62 ratio	Geometric Coefficient of Variation 55.3
Mavrilimumab 150 mg	Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169	0.58 ratio	Geometric Coefficient of Variation 61

p-value: 0.00395% CI: [0.58, 0.89]Repeated measures model

p-value: <0.00195% CI: [0.55, 0.84]Repeated measures model

p-value: <0.00195% CI: [0.49, 0.75]Repeated measures model

Secondary

Serum Concentrations of Mavrilimumab

Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.

Time frame: Baseline, Day 8, 15, 29, 85, 141, and 169

Population: The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each arm, respectively.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	Serum Concentrations of Mavrilimumab	Day 8 (n=78, 83, 78)	617.49 nanogram per milliliter	Geometric Coefficient of Variation 111.8
Placebo	Serum Concentrations of Mavrilimumab	Day 85 (n=74, 81, 77)	201.57 nanogram per milliliter	Geometric Coefficient of Variation 162.8
Placebo	Serum Concentrations of Mavrilimumab	Day 29 (n=77, 85, 76)	217.67 nanogram per milliliter	Geometric Coefficient of Variation 248.3
Placebo	Serum Concentrations of Mavrilimumab	Baseline (n=80, 85, 79)	0.00 nanogram per milliliter	Geometric Coefficient of Variation 894.4
Placebo	Serum Concentrations of Mavrilimumab	Day 169 (n=63, 73, 74)	348.97 nanogram per milliliter	Geometric Coefficient of Variation 141.2
Placebo	Serum Concentrations of Mavrilimumab	Day 141 (n=67, 75, 71)	258.77 nanogram per milliliter	Geometric Coefficient of Variation 136.9
Placebo	Serum Concentrations of Mavrilimumab	Day 15 (n=78, 84, 78)	154.60 nanogram per milliliter	Geometric Coefficient of Variation 194.2
Mavrilimumab 30 mg	Serum Concentrations of Mavrilimumab	Day 29 (n=77, 85, 76)	4503.97 nanogram per milliliter	Geometric Coefficient of Variation 54.8
Mavrilimumab 30 mg	Serum Concentrations of Mavrilimumab	Baseline (n=80, 85, 79)	0.00 nanogram per milliliter	—
Mavrilimumab 30 mg	Serum Concentrations of Mavrilimumab	Day 8 (n=78, 83, 78)	3563.31 nanogram per milliliter	Geometric Coefficient of Variation 49.3
Mavrilimumab 30 mg	Serum Concentrations of Mavrilimumab	Day 15 (n=78, 84, 78)	2479.96 nanogram per milliliter	Geometric Coefficient of Variation 52.1
Mavrilimumab 30 mg	Serum Concentrations of Mavrilimumab	Day 85 (n=74, 81, 77)	6538.22 nanogram per milliliter	Geometric Coefficient of Variation 52.7
Mavrilimumab 30 mg	Serum Concentrations of Mavrilimumab	Day 141 (n=67, 75, 71)	2932.80 nanogram per milliliter	Geometric Coefficient of Variation 75.6
Mavrilimumab 30 mg	Serum Concentrations of Mavrilimumab	Day 169 (n=63, 73, 74)	5282.37 nanogram per milliliter	Geometric Coefficient of Variation 62
Mavrilimumab 100 mg	Serum Concentrations of Mavrilimumab	Day 85 (n=74, 81, 77)	13213.93 nanogram per milliliter	Geometric Coefficient of Variation 50.1
Mavrilimumab 100 mg	Serum Concentrations of Mavrilimumab	Day 8 (n=78, 83, 78)	6087.06 nanogram per milliliter	Geometric Coefficient of Variation 43.4
Mavrilimumab 100 mg	Serum Concentrations of Mavrilimumab	Day 169 (n=63, 73, 74)	9178.47 nanogram per milliliter	Geometric Coefficient of Variation 56.6
Mavrilimumab 100 mg	Serum Concentrations of Mavrilimumab	Day 141 (n=67, 75, 71)	9241.31 nanogram per milliliter	Geometric Coefficient of Variation 52.1
Mavrilimumab 100 mg	Serum Concentrations of Mavrilimumab	Day 29 (n=77, 85, 76)	7843.66 nanogram per milliliter	Geometric Coefficient of Variation 42.9
Mavrilimumab 100 mg	Serum Concentrations of Mavrilimumab	Day 15 (n=78, 84, 78)	4616.35 nanogram per milliliter	Geometric Coefficient of Variation 42.6
Mavrilimumab 100 mg	Serum Concentrations of Mavrilimumab	Baseline (n=80, 85, 79)	0.00 nanogram per milliliter	Geometric Coefficient of Variation 862

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026

A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85

Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169

Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169

Dyspnea Score at Day 169

Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169

Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169

Mean Change From Baseline in Patient Assessment of Pain at Day 169

Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169

Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169

Mean Change From Baseline in Swollen and Tender Joint Count at Day 169

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)

Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

Oxygen Saturation Level at Day 169

Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit

Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169

Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169

Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169

Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169

Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169

Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169

Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169

Serum Concentrations of Mavrilimumab