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A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With 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: NCT01050998
Recruitment Status : Completed
First Posted : January 18, 2010
Results First Posted : February 16, 2017
Last Update Posted : June 25, 2018
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 10 mg
Biological: Mavrilimumab 30 mg
Biological: Mavrilimumab 50 mg
Biological: Mavrilimumab 100 mg
Other: Placebo
Enrollment 516
Recruitment Details  
Pre-assignment Details A total of 516 participants were screened out of which 290 participants were randomized in the study.
Arm/Group Title Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg Placebo
Hide Arm/Group Description Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Period Title: Overall Study
Started 48 49 49 48 96
Completed 44 47 46 45 82
Not Completed 4 2 3 3 14
Reason Not Completed
Adverse Event             1             0             1             0             2
Withdrawal by Subject             0             0             0             1             3
Other             3             2             1             1             5
Data integrity issues             0             0             1             1             4
Arm/Group Title Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg Placebo Total
Hide Arm/Group Description Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. Total of all reporting groups
Overall Number of Baseline Participants 48 49 48 47 92 284
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population constituted all participants who were randomized into the study regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 49 participants 48 participants 47 participants 92 participants 284 participants
52.2  (11.9) 51.1  (12.1) 52.7  (10.3) 50.1  (12.1) 52.1  (12.8) 51.7  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 48 participants 47 participants 92 participants 284 participants
Female
39
  81.3%
43
  87.8%
44
  91.7%
40
  85.1%
82
  89.1%
248
  87.3%
Male
9
  18.8%
6
  12.2%
4
   8.3%
7
  14.9%
10
  10.9%
36
  12.7%
1.Primary Outcome
Title Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response 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 Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
32.6 37.5 63.3 47.9 68.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.578
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%
-11.5 to 22.0
Estimation Comments 95 percent (%) unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 30.7
Confidence Interval (2-Sided) 95%
13.4 to 46.3
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 15.3
Confidence Interval (2-Sided) 95%
-1.6 to 32.2
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 35.5
Confidence Interval (2-Sided) 95%
17.8 to 50.6
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
2.Primary Outcome
Title Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region
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. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
European Region (n=75, 39, 41, 39, 39) 34.7 41.0 61.0 51.3 66.7
Japanese Region (n=17, 9, 8, 9, 8) 23.5 22.2 75.0 33.3 75.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
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%
-11.9 to 25.4
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 26.3
Confidence Interval (2-Sided) 95%
7.2 to 43.6
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 16.6
Confidence Interval (2-Sided) 95%
-2.5 to 35.5
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 32.0
Confidence Interval (2-Sided) 95%
12.5 to 49.0
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Japanese region: p-value was calculated using a two-tailed Fisher's exact test.
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 -1.3
Confidence Interval (2-Sided) 95%
-33.7 to 35.7
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg, Mavrilimumab 100 mg
Comments Japanese region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 51.5
Confidence Interval (2-Sided) 95%
8.2 to 77.0
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Japanese region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
-24.3 to 46.9
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
3.Primary Outcome
Title Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85
Hide Description DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
37.0 50.0 61.2 58.3 66.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
-4.2 to 30.3
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 24.3
Confidence Interval (2-Sided) 95%
7.0 to 40.3
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 21.4
Confidence Interval (2-Sided) 95%
3.9 to 37.8
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 29.0
Confidence Interval (2-Sided) 95%
11.3 to 45.0
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
4.Primary Outcome
Title Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region
Hide Description DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. DAS28 (ESR) response at Day 85 for the European and Japanese regions were reported.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
European Region (n=75, 39, 41, 39, 39) 41.3 51.3 58.5 61.5 64.1
Japanese Region (n=17, 9, 8, 9, 8) 17.6 44.4 75.0 44.4 75.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
-9.3 to 29.4
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 17.2
Confidence Interval (2-Sided) 95%
-2.0 to 35.6
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 20.2
Confidence Interval (2-Sided) 95%
0.7 to 38.2
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments European region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 22.8
Confidence Interval (2-Sided) 95%
3.2 to 40.7
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg, Mavrilimumab 50 mg
Comments Japanese region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 26.8
Confidence Interval (2-Sided) 95%
-9.3 to 60.7
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg, Mavrilimumab 100 mg
Comments Japanese region: p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 57.4
Confidence Interval (2-Sided) 95%
15.2 to 81.8
Estimation Comments 95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.
5.Primary Outcome
Title Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85
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 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
No response 51.1 47.9 28.6 35.4 23.4
Moderate response 34.8 31.3 38.8 41.7 42.6
Good response 14.1 20.8 32.7 22.9 34.0
6.Primary Outcome
Title Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region
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 =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
European: No response (n=75,39,41,39,39) 49.3 46.2 29.3 33.3 23.1
European: Moderate response (n=75,39,41,39,39) 36.0 33.3 41.5 41.0 46.2
European: Good response (n=75,39,41,39,39) 14.7 20.5 29.3 25.6 30.8
Japanese: No response (n=17,9,8,9,8) 58.8 55.6 25.0 44.4 25.0
Japanese: Moderate response (n=17,9,8,9,8) 29.4 22.2 25.0 44.4 25.0
Japanese: Good response (n=17,9,8,9,8) 11.8 22.2 50.0 11.1 50.0
7.Primary Outcome
Title Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85
Hide Description DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
No response 55.4 39.6 36.7 33.3 25.5
Moderate response 35.9 45.8 44.9 54.2 53.2
Good response 8.7 14.6 18.4 12.5 21.3
8.Primary Outcome
Title Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region
Hide Description DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1. DAS28 (ESR) response by EULAR category at Day 85 for the European and Japanese regions were reported.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
European: No response (n=75,39,41,39,39) 53.3 38.5 39.0 33.3 28.2
European: Moderate response (n=75,39,41,39,39) 38.7 46.2 43.9 53.8 51.3
European: Good response (n=75,39,41,39,39) 8.0 15.4 17.1 12.8 20.5
Japanese: No response (n=17,9,8,9,8) 64.7 44.4 25.0 33.3 12.5
Japanese: Moderate response (n=17,9,8,9,8) 23.5 44.4 50.0 55.6 62.5
Japanese: Good response (n=17,9,8,9,8) 11.8 11.1 25.0 11.1 25.0
9.Primary Outcome
Title Number 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 up Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to Day 169 (follow-up)
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Measure Type: Number
Unit of Measure: participants
TEAEs 46 33 31 26 28
TESAEs 1 2 2 1 0
10.Primary 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, and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
Time Frame Baseline up to Day 169 (follow-up)
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Measure Type: Number
Unit of Measure: participants
Pyrexia 1 0 0 2 0
Hypertension 2 0 1 0 0
11.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Results
Hide Description 12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator's discretion were reported.
Time Frame Baseline up to Day 169 (follow-up)
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Measure Type: Number
Unit of Measure: participants
0 1 0 0 2
12.Primary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85
Hide Description FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame Day 85
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 87 46 47 49 47
Mean (Standard Deviation)
Unit of Measure: liters
FEV1 2.730  (0.764) 2.877  (0.821) 2.949  (0.722) 2.701  (0.489) 2.793  (0.690)
FVC 3.439  (0.949) 3.582  (0.967) 3.667  (0.882) 3.370  (0.527) 3.499  (0.766)
13.Primary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region
Hide Description FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC at Day 85 for the European and Japanese regions were reported.
Time Frame Day 85
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 and "n" signifies participants who were evaluable for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 87 46 47 49 47
Mean (Standard Deviation)
Unit of Measure: liters
European: FEV1 (n=71,37,39,40,39) 2.811  (0.790) 2.902  (0.810) 3.042  (0.745) 2.698  (0.501) 2.848  (0.699)
European: FVC (n=71,37,39,40,39) 3.537  (0.996) 3.632  (0.948) 3.779  (0.917) 3.355  (0.537) 3.553  (0.772)
Japanese: FEV1 (n=16,9,8,9,8) 2.367  (0.510) 2.774  (0.908) 2.493  (0.354) 2.712  (0.457) 2.520  (0.616)
Japanese: FVC (n=16,9,8,9,8) 3.005  (0.534) 3.378  (1.076) 3.119  (0.370) 3.434  (0.505) 3.235  (0.725)
14.Primary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85
Hide Description FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame Baseline and Day 85
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 at the specified time point for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Mean (Standard Deviation)
Unit of Measure: liters
Baseline: FEV1 (n=87,43,45,49,48) 2.790  (0.770) 2.788  (0.773) 2.990  (0.765) 2.760  (0.430) 2.831  (0.681)
Change at Day 85: FEV1 (n=87,46,47,49,47) -0.039  (0.234) 0.044  (0.231) 0.016  (0.196) -0.059  (0.249) -0.049  (0.221)
Baseline: FVC (n=87,43,45,49,48) 3.456  (0.948) 3.486  (0.963) 3.759  (0.868) 3.409  (0.496) 3.506  (0.804)
Change at Day 85: FVC (n=87,46,47,49,47) -0.012  (0.301) 0.048  (0.243) -0.013  (0.239) -0.039  (0.268) -0.017  (0.218)
15.Primary Outcome
Title Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85
Hide Description DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide.
Time Frame Day 85
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 87 46 47 49 47
Mean (Standard Deviation)
Unit of Measure: percent diffusion capacity
91.7  (16.7) 95.0  (16.2) 95.0  (15.1) 95.0  (15.7) 89.3  (12.0)
16.Primary Outcome
Title Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region
Hide Description DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported.
Time Frame Day 85
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 and "n" signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 87 46 47 49 47
Mean (Standard Deviation)
Unit of Measure: percent diffusion capacity
European region: (n=71,37,39,40,39) 90.4  (16.5) 96.0  (16.9) 94.0  (15.2) 94.8  (16.5) 88.6  (10.7)
Japanese region (n=16,9,8,9,8) 97.6  (16.9) 91.0  (13.3) 100.1  (14.6) 96.0  (12.6) 93.0  (17.2)
17.Primary Outcome
Title Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85
Hide Description DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide.
Time Frame Baseline and Day 85
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 at the specified time point for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Mean (Standard Deviation)
Unit of Measure: percent diffusion capacity
Baseline (n=86,40,45,49,48) 91.5  (12.5) 96.3  (17.7) 93.7  (15.5) 97.5  (14.8) 92.5  (13.7)
Change at Day 85 (n=87,46,47,49,47) 0.1  (14.3) -3.1  (17.3) 0.4  (11.1) -2.5  (10.8) -3.7  (11.3)
18.Primary Outcome
Title Dyspnea Score at Day 85
Hide Description Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.
Time Frame Day 85
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 89 45 47 49 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.25  (0.48) 0.13  (0.38) 0.35  (0.70) 0.15  (0.44) 0.35  (0.59)
19.Primary Outcome
Title Change From Baseline in Dyspnea Score at Day 85
Hide Description Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.
Time Frame Baseline and Day 85
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 at the specified time point for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=96,48,49,49,48) 0.29  (0.58) 0.26  (0.88) 0.26  (0.59) 0.19  (0.49) 0.32  (0.59)
Change at Day 85 (n=89,45,47,49,47) -0.06  (0.53) -0.14  (0.62) 0.10  (0.44) -0.04  (0.35) 0.02  (0.56)
20.Primary Outcome
Title Categorized Dyspnea Score at Day 85
Hide Description Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above).
Time Frame Day 85
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 89 45 47 49 47
Measure Type: Number
Unit of Measure: participants
No/Slight breathlessness 89 45 45 49 46
Moderate breathlessness 0 0 2 0 1
Severe breathlessness 0 0 0 0 0
Very severe breathlessness 0 0 0 0 0
21.Primary Outcome
Title Oxygen Saturation Level at Day 85
Hide Description Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Time Frame Day 85
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 88 45 47 49 47
Mean (Standard Deviation)
Unit of Measure: percent saturation
97.5  (1.2) 97.6  (1.3) 97.7  (1.3) 97.2  (1.8) 97.3  (1.5)
22.Primary Outcome
Title Oxygen Saturation Level at Day 85 by Region
Hide Description Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported.
Time Frame Day 85
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 and "n" signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 88 45 47 49 47
Mean (Standard Deviation)
Unit of Measure: percent saturation
European region: (n=72,36,39,40,39) 97.5  (1.3) 97.6  (1.3) 97.6  (1.3) 97.2  (2.0) 97.3  (1.6)
Japanese region: (n=16,9,8,9,8) 97.6  (0.9) 97.4  (1.0) 98.4  (1.1) 97.4  (0.7) 97.3  (1.3)
23.Primary Outcome
Title Change From Baseline in Oxygen Saturation Level at Day 85
Hide Description Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Time Frame Baseline and Day 85
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 at the specified time point for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Mean (Standard Deviation)
Unit of Measure: percent saturation
Baseline (n=96,48,49,49,48) 97.5  (1.3) 97.8  (1.6) 97.6  (1.2) 97.6  (1.4) 97.2  (1.7)
Change at Day 85 (n=88,45,47,49,47) 0.0  (1.5) -0.2  (1.5) 0.1  (1.4) -0.3  (1.9) 0.1  (2.1)
24.Primary 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, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite).
Time Frame Baseline up to Day 169 (follow-up)
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 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 96 48 49 49 48
Measure Type: Number
Unit of Measure: participants
Blood and lymphatic system disorders 10 3 3 3 4
Hepatic abnormality 3 5 3 2 3
Blood cholesterol increased 0 0 0 1 0
Blood triglycerides increased 1 0 0 0 0
Hypercholesterolemia 1 1 1 1 0
Hyperglycemia 1 0 0 1 0
Urinalysis abnormalities 3 0 3 1 0
25.Secondary Outcome
Title Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85
Hide Description DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission.
Time Frame Baseline and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Mean (Standard Error)
Unit of Measure: units on a scale
DAS28(CRP): Baseline (n=92,48,49,48,47) 5.43  (0.110) 5.24  (0.160) 5.42  (0.139) 5.14  (0.146) 5.34  (0.115)
DAS28(CRP): Change at Day 85 (n=84,45,46,48,46) -0.97  (0.120) -1.27  (0.166) -1.63  (0.163) -1.32  (0.162) -1.70  (0.165)
DAS28(ESR): Baseline: (n=92,48,49,48,47) 6.18  (0.118) 6.06  (0.165) 6.31  (0.145) 5.98  (0.163) 6.06  (0.119)
DAS28(ESR): Change at Day 85 (n=85,45,47,48,46) -1.04  (0.125) -1.39  (0.172) -1.80  (0.170) -1.46  (0.168) -1.84  (0.172)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.71 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.205
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 30 mg
Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
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 -0.67
Confidence Interval (2-Sided) 95%
-1.07 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.202
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 50 mg
Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.75 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.201
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 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
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 -0.74
Confidence Interval (2-Sided) 95%
-1.14 to -0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.204
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 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.76 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.212
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 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
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 -0.76
Confidence Interval (2-Sided) 95%
-1.17 to -0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.210
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 7
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.83 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.209
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 8
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
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 -0.80
Confidence Interval (2-Sided) 95%
-1.22 to -0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.212
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.
26.Secondary Outcome
Title Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region
Hide Description DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.
Time Frame Baseline and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Mean (Standard Error)
Unit of Measure: units on a scale
European: DAS28(CRP): Baseline (n=75,39,41,39,39) 5.58  (0.117) 5.30  (0.172) 5.48  (0.154) 5.33  (0.155) 5.41  (0.111)
European: DAS28(CRP): Day 85 (n=68,36,38,39,38) -1.00  (0.133) -1.40  (0.187) -1.55  (0.181) -1.43  (0.181) -1.70  (0.183)
Japanese: DAS28(CRP): Baseline (n=17,9,8,9,8) 4.75  (0.242) 5.00  (0.427) 5.12  (0.306) 4.32  (0.268) 5.04  (0.413)
Japanese: DAS28(CRP): Day 85 (n=16,9,8,9,8) -0.85  (0.281) -0.73  (0.358) -2.04  (0.381) -0.89  (0.361) -1.71  (0.380)
European: DAS28(ESR): Baseline (n=75,39,41,39,39) 6.36  (0.124) 6.10  (0.180) 6.36  (0.163) 6.23  (0.159) 6.12  (0.118)
European: DAS28(ESR): Day 85 (n=69,36,39,39,38) -1.12  (0.140) -1.51  (0.196) -1.76  (0.190) -1.53  (0.190) -1.85  (0.193)
Japanese: DAS28(ESR): Baseline (n=17,9,8,9,8) 5.38  (0.248) 5.87  (0.426) 6.05  (0.309) 4.93  (0.379) 5.78  (0.404)
Japanese: DAS28(ESR): Day 85 (n=16,9,8,9,8) -0.74  (0.276) -0.83  (0.359) -1.99  (0.382) -1.24  (0.362) -1.78  (0.380)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.85 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.230
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 30 mg
Comments European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.99 to -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.225
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 50 mg
Comments European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.87 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.225
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 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.14 to -0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.227
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 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.87 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.241
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 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.11 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.236
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 7
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.88 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.236
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 8
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-1.20 to -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.238
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 9
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.785
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.78 to 1.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.447
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 10
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
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 -1.19
Confidence Interval (2-Sided) 95%
-2.13 to -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.465
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 11
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.931
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.94 to 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.448
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 12
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.80 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.465
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 13
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
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%
-0.99 to 0.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.449
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 14
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-2.19 to -0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.468
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 15
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-1.40 to 0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.448
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 16
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.03
Confidence Interval (2-Sided) 95%
-1.97 to -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.465
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.
27.Secondary Outcome
Title Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85
Hide Description DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
DAS28(CRP) 7.6 14.6 22.4 18.8 23.4
DAS28(ESR) 3.3 6.3 8.2 8.3 6.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
-3.3 to 20.5
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 14.8
Confidence Interval (2-Sided) 95%
2.8 to 29.7
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
0.0 to 25.4
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 15.8
Confidence Interval (2-Sided) 95%
2.9 to 31.0
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.412
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-4.2 to 14.0
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.237
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%
-2.9 to 16.4
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
-2.8 to 16.8
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.406
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
-4.1 to 14.4
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
28.Secondary Outcome
Title Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region
Hide Description DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Measure Type: Number
Unit of Measure: percentage of participants
European: DAS28(CRP):(n=75,39,41,39,39) 6.7 15.4 17.1 17.9 23.1
European: DAS28(ESR):(n=75,39,41,39,39) 1.3 7.7 9.8 7.7 7.7
Japanese: DAS28(CRP) (n=17,9,8,9,8) 11.8 11.1 50.0 22.2 25.0
Japanese: DAS28(ESR) (n=17,9,8,9,8) 11.8 0.0 0.0 11.1 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 8.7
Confidence Interval (2-Sided) 95%
-2.7 to 24.4
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 10.4
Confidence Interval (2-Sided) 95%
-1.2 to 25.5
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 11.3
Confidence Interval (2-Sided) 95%
-0.6 to 26.9
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 16.4
Confidence Interval (2-Sided) 95%
3.5 to 32.7
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg, Mavrilimumab 50 mg, Mavrilimumab 100 mg
Comments European region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.115
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%
-1.0 to 19.3
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments European region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 8.4
Confidence Interval (2-Sided) 95%
0.6 to 21.6
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
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 -0.7
Confidence Interval (2-Sided) 95%
-27.0 to 34.8
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 38.2
Confidence Interval (2-Sided) 95%
1.6 to 71.2
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.591
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 10.5
Confidence Interval (2-Sided) 95%
-18.2 to 46.2
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.570
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 13.2
Confidence Interval (2-Sided) 95%
-16.6 to 51.4
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Japanese region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.529
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -11.8
Confidence Interval (2-Sided) 95%
-35.0 to 22.7
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg, Mavrilimumab 100 mg
Comments Japanese region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher's exact test.
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 -11.8
Confidence Interval (2-Sided) 95%
-37.5 to 22.6
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Japanese region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher's exact test.
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 -0.7
Confidence Interval (2-Sided) 95%
-27.0 to 34.8
Estimation Comments 95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.
29.Secondary Outcome
Title Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission
Hide Description DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score.
Time Frame Baseline up to Day 169 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Median (95% Confidence Interval)
Unit of Measure: days
DAS28 (CRP) Response
88.0
(57.0 to 88.0)
84.0 [1] 
(43.0 to NA)
43.0
(29.0 to 58.0)
71.0
(42.0 to 89.0)
42.0
(29.0 to 45.0)
DAS28 (CRP) Remission
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
DAS28 (ESR) Response
85.0
(57.0 to 88.0)
58.0
(43.0 to 86.0)
30.0
(29.0 to 43.0)
57.0
(29.0 to 71.0)
29.0
(28.0 to 42.0)
DAS28 (ESR) Remission
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of CI was not estimable since low number of participants achieved response in this arm.
[2]
Median and 95% CI were not estimable since less than 50% of the participants achieved remission in this group.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg, Mavrilimumab 100 mg
Comments Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.282
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg, Mavrilimumab 100 mg
Comments Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
30.Secondary Outcome
Title Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region
Hide Description DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved.
Time Frame Baseline up to Day 169 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here "n" signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
Arm/Group Title Placebo Mavrilimumab 10 mg Mavrilimumab 30 mg Mavrilimumab 50 mg Mavrilimumab 100 mg
Hide Arm/Group Description:
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Overall Number of Participants Analyzed 92 48 49 48 47
Median (95% Confidence Interval)
Unit of Measure: days
European: DAS28 (CRP) Response (n=75,39,41,39,39)
85.0
(57.0 to 88.0)
43.0 [1] 
(43.0 to NA)
43.0
(42.0 to 71.0)
50.0
(29.0 to 89.0)
42.0
(29.0 to 57.0)
Japanese: DAS28 (CRP) Response (n=17,9,8,9,8)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
22.5
(15.0 to 57.0)
87.0
(30.0 to 87.0)
37.0
(15.0 to 57.0)
European: DAS28 (ESR) Response (n=75,39,41,39,39)
71.0
(57.0 to 88.0)
57.0
(30.0 to 85.0)
42.0
(29.0 to 43.0)
52.5
(29.0 to 84.0)
29.0
(28.0 to 42.0)
Japanese: DAS28 (ESR) Response (n=17,9,8,9,8)
NA [2] 
(NA to NA)
86.0
(57.0 to 86.0)
29.0
(15.0 to 44.0)
44.5 [1] 
(29.0 to NA)
30.0
(15.0 to 44.0)
[1]
Upper limit of CI was not estimable since low number of participants achieved response in this arm.
[2]
Median and 95% CI were not estimable since less than 50% of the participants achieved response in this group.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments European region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.237
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments European region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments European region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments European region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Japanese region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.265
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Japanese region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Japanese region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.952
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
Comments Japanese region: Analysis reported for DAS28 (CRP) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments European region: Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg, Mavrilimumab 100 mg
Comments European region: Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments European region: Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 10 mg
Comments Japanese region: Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.831
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
Comments Japanese region: Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 50 mg
Comments Japanese region: Analysis reported for DAS28 (ESR) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Gro