Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01706926
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : September 27, 2016
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
MedImmune Ltd
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: Mavrilimumab 30 mg
Biological: Mavrilimumab 100 mg
Biological: Mavrilimumab 150 mg
Other: Placebo
Enrollment 420
Recruitment Details  
Pre-assignment Details A total of 420 participants were screened out of which 326 participants were randomized and received investigational product in the study.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 81 81 85 79
Completed 75 77 79 74
Not Completed 6 4 6 5
Reason Not Completed
Lost to Follow-up             0             0             1             0
Withdrawal by Subject             2             0             1             2
Other             4             4             4             3
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 81 81 85 79 326
Hide Baseline Analysis Population Description
The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 81 participants 85 participants 79 participants 326 participants
52.8  (10.6) 51.2  (11.6) 50.8  (11.9) 52.6  (10.3) 51.8  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 81 participants 85 participants 79 participants 326 participants
Female
75
  92.6%
70
  86.4%
70
  82.4%
67
  84.8%
282
  86.5%
Male
6
   7.4%
11
  13.6%
15
  17.6%
12
  15.2%
44
  13.5%
1.Primary Outcome
Title Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=81, 81, 85, 79) 5.78  (0.090) 5.73  (0.104) 5.91  (0.096) 5.67  (0.086)
Change at Day 85 (n=77, 76, 79, 78) -0.68  (0.136) -1.37  (0.136) -1.64  (0.132) -1.90  (0.136)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-1.06 to -0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.193
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.33 to -0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.190
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-1.60 to -0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.193
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
24.7 50.6 61.2 73.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 25.9
Confidence Interval (2-Sided) 95%
11.5 to 40.3
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 36.5
Confidence Interval (2-Sided) 95%
22.5 to 50.5
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 48.7
Confidence Interval (2-Sided) 95%
35.2 to 62.3
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
3.Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any dose of investigational product.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
TEAEs 46.9 50.6 42.4 54.4
TESAEs 1.2 4.9 5.9 2.5
4.Secondary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any dose of investigational product.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: participants
Anemia 1 1 0 0
Eosinophilia 0 0 1 0
Leukocytosis 2 0 0 0
Lymphopenia 0 0 0 1
Neutropenia 1 0 0 3
Alanine aminotransferase increased 0 1 1 1
Aspartate aminotransferase increased 0 1 1 0
Gamma-glutamyltransferase increased 0 1 0 0
Hypertransaminasaemia 0 0 2 2
Dislipidaemia 0 0 1 0
Hypercholesterolaemia 1 0 1 0
Hyperlipidaemia 0 2 0 3
Hyperkalaemia 0 0 0 1
5.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any dose of investigational product.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: participants
Hypertension 2 4 4 3
Weight increased 1 1 1 0
Pyrexia 0 1 0 0
Hot flush 0 0 1 0
6.Secondary Outcome
Title Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percent of pulmonary test values
FEV1 =<15% (n=42,67,75,75) 97.6 98.5 96.0 89.3
FEV1 >15 to 20% (n=42,67,75,75) 0.0 0.0 1.3 6.7
FEV1 >20% (n=42,67,75,75) 2.4 1.5 2.7 4.0
FEV6 =<15% (n=41,66,71,68) 97.6 97.0 94.4 89.7
FEV6 >15 to 20% (n=41,66,71,68) 0.0 1.5 1.4 1.5
FEV6 >20% (n=41,66,71,68) 2.4 1.5 4.2 8.8
FVC =<15% (n=42,67,75,75) 97.6 98.5 94.7 94.7
FVC >15 to 20% (n=42,67,75,75) 0.0 0.0 1.3 2.7
FVC >20% (n=42,67,75,75) 2.4 1.5 4.0 2.7
7.Secondary Outcome
Title Dyspnea Score at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 41 65 73 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.38  (0.62) 0.22  (0.54) 0.32  (0.73) 0.28  (0.64)
8.Secondary Outcome
Title Oxygen Saturation Level at Day 169
Hide Description Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 40 65 73 74
Mean (Standard Deviation)
Unit of Measure: percent saturation
97.4  (1.4) 97.4  (1.1) 97.4  (1.1) 97.3  (1.2)
9.Secondary Outcome
Title Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
12.3 28.4 25.9 40.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 16.0
Confidence Interval (2-Sided) 95%
3.9 to 28.2
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
1.8 to 25.3
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 28.2
Confidence Interval (2-Sided) 95%
15.2 to 41.1
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
10.Secondary Outcome
Title Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
3.7 12.3 10.6 13.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 8.6
Confidence Interval (2-Sided) 95%
0.4 to 16.9
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 6.9
Confidence Interval (2-Sided) 95%
-0.8 to 14.6
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 10.2
Confidence Interval (2-Sided) 95%
1.5 to 18.9
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.
11.Secondary Outcome
Title Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 38 63 72 74
Mean (Standard Error)
Unit of Measure: units on a scale
13.25  (4.630) 29.04  (3.828) 30.24  (3.623) 40.72  (3.644)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean difference
Estimated Value 15.79
Confidence Interval (2-Sided) 95%
3.96 to 27.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.007
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 16.99
Confidence Interval (2-Sided) 95%
5.42 to 28.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.879
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 27.47
Confidence Interval (2-Sided) 95%
15.87 to 39.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.892
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.
12.Secondary Outcome
Title Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
No response 65.4 30.9 28.2 19.0
Moderate response 25.9 35.8 40.0 41.8
Good response 8.6 33.3 31.8 39.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Proportional odds analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.70
Confidence Interval (2-Sided) 95%
2.56 to 8.80
Estimation Comments Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (>) one favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Proportional odds analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.81
Confidence Interval (2-Sided) 95%
2.64 to 8.92
Estimation Comments Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios >one favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Proportional odds analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.11
Confidence Interval (2-Sided) 95%
3.85 to 13.40
Estimation Comments Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios >one favored mavrilimumab.
13.Secondary Outcome
Title Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
DAS28 (CRP) Remission 4.9 21.0 17.6 19.0
Low Disease Activity 8.6 33.3 31.8 41.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 16.0
Confidence Interval (2-Sided) 95%
6.0 to 26.1
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
3.3 to 22.1
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 14.0
Confidence Interval (2-Sided) 95%
4.2 to 23.9
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments The analysis reported DAS28 (CRP) low disease activity response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 24.7
Confidence Interval (2-Sided) 95%
12.7 to 36.6
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments The analysis reported DAS28 (CRP) low disease activity response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 23.1
Confidence Interval (2-Sided) 95%
11.5 to 34.8
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments The analysis reported DAS28 (CRP) low disease activity response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 33.1
Confidence Interval (2-Sided) 95%
20.7 to 45.6
Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
14.Secondary Outcome
Title Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Mean (Standard Error)
Unit of Measure: joint count
SJC: Baseline (n=81,81,85,79) 14.44  (0.765) 17.80  (1.126) 16.82  (0.930) 15.72  (0.795)
SJC: Change at Day 169 (n=40,65,73,74) -4.97  (0.932) -10.65  (0.809) -11.18  (0.771) -11.96  (0.787)
TJC: Baseline (n=81,81,85,79) 26.26  (1.250) 27.48  (1.553) 26.96  (1.544) 26.70  (1.284)
TJC: Change at Day 169 (n=40,65,73,74) -7.90  (1.447) -15.14  (1.265) -16.35  (1.207) -18.32  (1.234)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Analysis reported for change from baseline in swollen joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.68
Confidence Interval (2-Sided) 95%
-8.12 to -3.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.237
Estimation Comments 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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Analysis reported for change from baseline in swollen joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -6.21
Confidence Interval (2-Sided) 95%
-8.60 to -3.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.211
Estimation Comments 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.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments Analysis reported for change from baseline in swollen joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.00
Confidence Interval (2-Sided) 95%
-9.40 to -4.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.219
Estimation Comments 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.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Analysis reported for change from baseline in tender joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.24
Confidence Interval (2-Sided) 95%
-11.02 to -3.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.922
Estimation Comments 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.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Analysis reported for change from baseline in tender joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -8.45
Confidence Interval (2-Sided) 95%
-12.16 to -4.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.884
Estimation Comments 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.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments Analysis reported for change from baseline in tender joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -10.42
Confidence Interval (2-Sided) 95%
-14.17 to -6.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.901
Estimation Comments 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.
15.Secondary Outcome
Title Mean Change From Baseline in Patient Assessment of Pain at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Mean (Standard Error)
Unit of Measure: mm
Baseline (n=81, 81, 85, 79) 62.16  (2.093) 62.65  (2.110) 63.58  (2.034) 62.35  (2.217)
Change at Day 169 (n=40, 65, 73, 74) -15.20  (3.006) -23.14  (2.563) -23.31  (2.446) -26.53  (2.483)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.94
Confidence Interval (2-Sided) 95%
-15.72 to -0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.950
Estimation Comments 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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -8.11
Confidence Interval (2-Sided) 95%
-15.73 to -0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.876
Estimation Comments 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.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -11.32
Confidence Interval (2-Sided) 95%
-19.00 to -3.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.899
Estimation Comments 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.
16.Secondary Outcome
Title Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Mean (Standard Error)
Unit of Measure: mm
Baseline (n=81, 81, 85, 79) 64.86  (1.892) 63.79  (2.074) 63.71  (1.957) 62.39  (2.099)
Change at Day 169 (n=40, 65, 73, 74) -20.21  (3.148) -21.06  (2.685) -22.40  (2.560) -25.69  (2.600)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-8.99 to 7.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.137
Estimation Comments 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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.589
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.19
Confidence Interval (2-Sided) 95%
-10.18 to 5.79
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.058
Estimation Comments 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.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.180
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.48
Confidence Interval (2-Sided) 95%
-13.52 to 2.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.083
Estimation Comments 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.
17.Secondary Outcome
Title Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Mean (Standard Error)
Unit of Measure: cm
Baseline (n=81, 81, 85, 79) 6.60  (0.168) 6.60  (0.162) 6.81  (0.144) 6.42  (0.166)
Change at Day 169 (n=40, 65, 73, 74) -2.39  (0.305) -3.81  (0.254) -3.85  (0.241) -3.95  (0.243)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-2.20 to -0.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.397
Estimation Comments 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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.46
Confidence Interval (2-Sided) 95%
-2.23 to -0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.389
Estimation Comments 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.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.56
Confidence Interval (2-Sided) 95%
-2.33 to -0.79
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.391
Estimation Comments 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.
18.Secondary Outcome
Title Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=81, 80, 85, 79) 1.63  (0.054) 1.52  (0.070) 1.58  (0.056) 1.58  (0.059)
Change at Day 169 (n=40, 65, 73, 74) -0.29  (0.081) -0.37  (0.072) -0.46  (0.068) -0.55  (0.069)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.479
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.29 to 0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.108
Estimation Comments 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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.37 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.106
Estimation Comments 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.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.47 to -0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.107
Estimation Comments 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.
19.Secondary Outcome
Title Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 38 63 72 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.2971
(83.3%)
0.8784
(102.8%)
0.5197
(287.4%)
0.5856
(153.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.45 to 0.92
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.32 to 0.66
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.31 to 0.63
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
20.Secondary Outcome
Title Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 40 64 73 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
0.89
(57.0%)
0.67
(56.4%)
0.62
(55.3%)
0.58
(61.0%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.58 to 0.89
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.55 to 0.84
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.49 to 0.75
Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
21.Secondary Outcome
Title Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
1.2 6.2 2.4 5.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-0.8 to 10.7
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-2.9 to 5.1
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.207
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-1.6 to 9.2
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
22.Secondary Outcome
Title Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
1.2 6.2 3.5 7.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-0.8 to 10.7
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-2.3 to 6.9
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
0.0 to 12.7
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
23.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
0.0 3.7 1.2 1.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
-0.4 to 7.8
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-1.1 to 3.5
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.494
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-1.2 to 3.7
Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
24.Secondary Outcome
Title Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=79, 80, 84, 79) 26.75  (0.824) 28.91  (1.078) 28.45  (0.998) 27.82  (0.950)
Change at Day 169 (n=40, 65, 73, 74) 4.53  (1.225) 5.72  (1.039) 6.80  (0.988) 8.45  (0.997)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
-1.99 to 4.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.608
Estimation Comments 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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.27
Confidence Interval (2-Sided) 95%
-0.83 to 5.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.574
Estimation Comments 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.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.92
Confidence Interval (2-Sided) 95%
0.81 to 7.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.578
Estimation Comments 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.
25.Secondary Outcome
Title Serum Concentrations of Mavrilimumab
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 81 85 79
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter
Baseline (n=80, 85, 79)
0.00
(894.4%)
0.00 [1] 
(NA%)
0.00
(862.0%)
Day 8 (n=78, 83, 78)
617.49
(111.8%)
3563.31
(49.3%)
6087.06
(43.4%)
Day 15 (n=78, 84, 78)
154.60
(194.2%)
2479.96
(52.1%)
4616.35
(42.6%)
Day 29 (n=77, 85, 76)
217.67
(248.3%)
4503.97
(54.8%)
7843.66
(42.9%)
Day 85 (n=74, 81, 77)
201.57
(162.8%)
6538.22
(52.7%)
13213.93
(50.1%)
Day 141 (n=67, 75, 71)
258.77
(136.9%)
2932.80
(75.6%)
9241.31
(52.1%)
Day 169 (n=63, 73, 74)
348.97
(141.2%)
5282.37
(62.0%)
9178.47
(56.6%)
[1]
Geometric coefficient of variation could not be calculated as mean and geometric mean were zero at this time point.
26.Secondary Outcome
Title Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 81 81 85 79
Measure Type: Number
Unit of Measure: percentage of participants
2.5 16.0 3.5 0.0
Time Frame Baseline up to Day 169
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/81 (1.23%)      4/81 (4.94%)      5/85 (5.88%)      2/79 (2.53%)    
Cardiac disorders         
Atrial tachycardia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Supraventricular tachycardia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Gastrointestinal disorders         
Dyspepsia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Infections and infestations         
Pneumonia  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Injury, poisoning and procedural complications         
Lower limb fracture  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Tendon rupture  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Rheumatoid arthritis  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of the cervix  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Squamous cell carcinoma of lung  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Reproductive system and breast disorders         
Cystocele  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Skin and subcutaneous tissue disorders         
Angioedema  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/81 (46.91%)      41/81 (50.62%)      36/85 (42.35%)      43/79 (54.43%)    
Blood and lymphatic system disorders         
Anaemia  1  1/81 (1.23%)  1 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Eosinophilia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Leukocytosis  1  2/81 (2.47%)  2 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Lymphopenia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Neutropenia  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 3/79 (3.80%)  4
Cardiac disorders         
Arrhythmia supraventricular  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Cardiac failure  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Cardiovascular insufficiency  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  0/81 (0.00%)  0 1/81 (1.23%)  1 1/85 (1.18%)  1 0/79 (0.00%)  0
Endocrine disorders         
Hypothyroidism  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 1/79 (1.27%)  1
Eye disorders         
Conjunctival haemorrhage  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Conjunctivitis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 2/85 (2.35%)  2 0/79 (0.00%)  0
Keratitis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Abdominal pain upper  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Cheilitis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Constipation  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Dental caries  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 1/79 (1.27%)  1
Diarrhoea  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 2/79 (2.53%)  2
Dyspepsia  1  1/81 (1.23%)  1 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Gastritis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 2/79 (2.53%)  2
Gingival swelling  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Haemorrhoids  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Irritable bowel syndrome  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Mouth cyst  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Nausea  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Vomiting  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
General disorders         
Fatigue  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Feeling hot  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Influenza like illness  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 1/79 (1.27%)  1
Injection site erythema  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  3
Injection site haematoma  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Injection site reaction  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Injection site swelling  1  1/81 (1.23%)  1 1/81 (1.23%)  2 0/85 (0.00%)  0 1/79 (1.27%)  2
Oedema peripheral  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Pyrexia  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Hepatobiliary disorders         
Hypertransaminasaemia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 2/85 (2.35%)  2 2/79 (2.53%)  2
Immune system disorders         
Allergy to arthropod bite  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Drug hypersensitivity  1  1/81 (1.23%)  1 1/81 (1.23%)  1 0/85 (0.00%)  0 2/79 (2.53%)  2
Hypersensitivity  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Infections and infestations         
Body tinea  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Bronchitis  1  6/81 (7.41%)  6 3/81 (3.70%)  3 1/85 (1.18%)  1 4/79 (5.06%)  4
Cellulitis  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Cystitis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 1/85 (1.18%)  1 0/79 (0.00%)  0
Ear infection  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Escherichia urinary tract infection  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Fungal skin infection  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 1/79 (1.27%)  1
Gastroenteritis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 2/79 (2.53%)  2
Gastrointestinal viral infection  1  2/81 (2.47%)  2 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Gingivitis  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Herpes simplex  1  2/81 (2.47%)  2 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Influenza  1  0/81 (0.00%)  0 1/81 (1.23%)  1 3/85 (3.53%)  3 1/79 (1.27%)  1
Lyme disease  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Nasopharyngitis  1  6/81 (7.41%)  6 4/81 (4.94%)  5 3/85 (3.53%)  4 6/79 (7.59%)  6
Omphalitis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Periodontitis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Pharyngitis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 1/79 (1.27%)  1
Pneumonia  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Respiratory tract infection viral  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 1/79 (1.27%)  1
Rhinitis  1  0/81 (0.00%)  0 2/81 (2.47%)  2 0/85 (0.00%)  0 2/79 (2.53%)  2
Sinusitis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Skin infection  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Tinea pedis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Tinea versicolour  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Tonsillitis  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Upper respiratory tract infection  1  1/81 (1.23%)  1 2/81 (2.47%)  2 1/85 (1.18%)  1 1/79 (1.27%)  1
Urinary tract infection  1  1/81 (1.23%)  1 2/81 (2.47%)  2 1/85 (1.18%)  1 1/79 (1.27%)  1
Viral upper respiratory tract infection  1  0/81 (0.00%)  0 2/81 (2.47%)  2 1/85 (1.18%)  1 1/79 (1.27%)  1
Injury, poisoning and procedural complications         
Alcohol poisoning  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Animal bite  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Bone contusion  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Chemical poisoning  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Clavicle fracture  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Contusion  1  1/81 (1.23%)  1 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Epicondylitis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Fall  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Injection related reaction  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Laceration  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Limb injury  1  0/81 (0.00%)  0 0/81 (0.00%)  0 2/85 (2.35%)  2 0/79 (0.00%)  0
Muscle contusion  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 1/79 (1.27%)  1
Investigations         
Alanine aminotransferase increased  1  0/81 (0.00%)  0 1/81 (1.23%)  1 1/85 (1.18%)  1 1/79 (1.27%)  1
Aspartate aminotransferase increased  1  0/81 (0.00%)  0 1/81 (1.23%)  1 1/85 (1.18%)  1 0/79 (0.00%)  0
Blood pressure increased  1  1/81 (1.23%)  2 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Weight increased  1  1/81 (1.23%)  1 1/81 (1.23%)  1 1/85 (1.18%)  1 0/79 (0.00%)  0
Metabolism and nutrition disorders         
Dyslipidaemia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Hypercholesterolaemia  1  1/81 (1.23%)  1 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Hyperkalaemia  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Hyperlipidaemia  1  0/81 (0.00%)  0 2/81 (2.47%)  2 0/85 (0.00%)  0 3/79 (3.80%)  3
Musculoskeletal and connective tissue disorders         
Back pain  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Joint swelling  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Muscle spasms  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/85 (1.18%)  1 0/79 (0.00%)  0
Osteoarthritis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Pain in extremity  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Rheumatoid arthritis  1  4/81 (4.94%)  6 2/81 (2.47%)  3 2/85 (2.35%)  2 0/79 (0.00%)  0
Rheumatoid nodule  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/85 (0.00%)  0 0/79 (0.00%)  0
Rotator cuff syndrome  1  0/81 (0.00%)  0 1/81 (1.23%)  1 1/85 (1.18%)  1 0/79 (0.00%)  0
Sjogren's syndrome  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0
Spinal osteoarthritis  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Spinal pain  1  0/81 (0.00%)  0 0/81 (0.00%)  0 0/85 (0.00%)  0 1/79 (1.27%)  1
Tendonitis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/85 (0.00%)  0 0/79 (0.00%)  0