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A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor 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: NCT01715896
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: Golimumab 50 mg
Biological: Mavrilimumab 100 mg
Enrollment 215
Recruitment Details  
Pre-assignment Details Overall, 215 participants were screened, of which 77 participants were considered as screen failures and 138 participants were randomized and completed in the study.
Arm/Group Title Golimumab 50 Milligram (mg) Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Period Title: Overall Study
Started 68 70
Completed 65 59
Not Completed 3 11
Reason Not Completed
Lost to Follow-up             0             2
Withdrawal by Subject             1             4
Other             2             5
Arm/Group Title Golimumab 50 Milligram (mg) Alternating With Placebo Mavrilimumab 100 mg Total
Hide Arm/Group Description Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Total of all reporting groups
Overall Number of Baseline Participants 68 70 138
Hide Baseline Analysis Population Description
The modified intent to treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 70 participants 138 participants
49.9  (11.4) 50.2  (13.3) 50.0  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 70 participants 138 participants
Female
57
  83.8%
56
  80.0%
113
  81.9%
Male
11
  16.2%
14
  20.0%
25
  18.1%
1.Primary Outcome
Title Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
Hide Description The ACR20 was defined as greater than or equal to (>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
65.6 62.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.666
Comments [Not Specified]
Method Logit response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -3.5
Confidence Interval (2-Sided) 90%
-16.8 to 9.8
Estimation Comments P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.
2.Primary Outcome
Title Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
Hide Description The ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
43.4 34.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.293
Comments [Not Specified]
Method Logit response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -8.6
Confidence Interval (2-Sided) 90%
-22.0 to 4.8
Estimation Comments P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.
3.Primary Outcome
Title Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
Hide Description The ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
25.9 16.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method Logit Response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -9.8
Confidence Interval (2-Sided) 90%
-21.1 to 1.4
Estimation Comments P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.
4.Primary Outcome
Title Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169
Hide Description The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
29.0 17.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Logit Response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -11.6
Confidence Interval (2-Sided) 90%
-23.2 to 0.0
Estimation Comments P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.
5.Primary Outcome
Title Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169
Hide Description The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
69.0 58.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2080
Comments [Not Specified]
Method Logit Response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -10.3
Confidence Interval (2-Sided) 90%
-23.7 to 3.0
Estimation Comments P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.
6.Secondary 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 Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.
Time Frame Baseline up to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of study medication.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: participants
TEAEs 29 36
TESAEs 3 2
Investigational-product-related TEAE 11 12
Severe TEAE 3 1
Acute TEAEs 7 5
Acute Severe TEAE 1 0
Investigational-product-related TESAE 2 0
7.Secondary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.
Time Frame Baseline up to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of investigational product.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: participants
Leukocytosis 0 2
Neutropenia 1 0
Anaemia of chronic disease 1 0
Alanine aminotransferase increased 2 0
Blood parathyroid hormone increased 0 1
Gamma-glutamyltransferase increased 1 0
Hepatic enzyme increased 2 3
Dyslipidaemia 2 0
Hypercholesterolaemia 2 0
Hyperglycaemia 0 1
Hyperlipidaemia 0 1
Hypertriglyceridaemia 0 1
Urinalysis 0 0
8.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
Time Frame Baseline up to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of study medication.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: participants
Hypertension 0 1
Pyrexia 2 0
9.Secondary Outcome
Title Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Hide Description Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (>) 20% reduction (RD) and absolute value (AV) less than (<) 80% predicted (PR).
Time Frame Day 85 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: participants
Day 85: FEV1 > 20% RD (n=64, 63) 1 0
Day 169: FEV1 > 20% RD (n=64, 64) 4 1
Day 85: FEV1 > 20% RD and AV < 80% PR (n=64, 63) 1 0
Day 169: FEV1 > 20% RD and AV < 80% PR (n=64, 64) 4 1
Day 85: FEV6 > 20% RD (n=54, 55) 1 1
Day 169: FEV6 > 20% RD (n=54, 56) 4 0
Day 85: FEV6 > 20% RD and AV < 80% PR (n=54, 55) 0 1
Day 169: FEV6 > 20% RD and AV < 80% PR (n=54, 56) 2 0
Day 85: FVC > 20% RD (n=64, 63) 0 0
Day 169: FVC > 20% RD (n=64, 64) 2 1
Day 85: FVC > 20% RD and AV < 80% PR (n=64, 63) 0 0
Day 169: FVC > 20% RD and AV < 80% PR (n=64, 64) 2 1
Day 85: DLCO > 15-20% RD (n=18, 21) 1 0
Day 169: DLCO > 15-20% RD (n=22, 23) 0 0
Day 85: DLCO > 20% RD (n=18, 21) 1 0
Day 169: DLCO > 20% RD (n=22, 23) 1 0
10.Secondary Outcome
Title Dyspnea Score at Day 169
Hide Description Borg dyspnea scale was 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 indicated greater difficulty in breathing.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of investigational product. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 64 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.34  (0.81) 0.42  (0.73)
11.Secondary Outcome
Title Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169
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.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=68, 70) 5.72  (0.83) 5.82  (0.96)
Day 169 (n=62, 62) -2.40  (1.42) -2.11  (1.30)
12.Secondary Outcome
Title Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169
Hide Description ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).
Time Frame Baseline up to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Mean (Standard Error)
Unit of Measure: units on a scale
40.49  (5.406) 33.06  (5.199)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean difference
Estimated Value -7.42
Confidence Interval (2-Sided) 90%
-17.24 to 2.40
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.
13.Secondary Outcome
Title American College of Rheumatology (ACR) Hybrid Score at Day 169
Hide Description ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Median (Full Range)
Unit of Measure: units on a scale
49.99
(-9.0 to 98.2)
41.66
(-1.0 to 90.3)
14.Secondary Outcome
Title Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
Hide Description DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: participants
No response 12 16
Moderate response 28 35
Good response 28 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method Proportional odds analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.61
Confidence Interval (2-Sided) 90%
0.36 to 1.04
Estimation Comments Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.
15.Secondary Outcome
Title Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
Hide Description DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: participants
DAS28 (CRP) Remission 20 12
Low Disease Activity 28 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -11.6
Confidence Interval 90%
-23.2 to 0.0
Estimation Comments 90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments The analysis reported DAS28 (CRP) low disease activity response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -11.7
Confidence Interval (2-Sided) 90%
-24.8 to 1.4
Estimation Comments 90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.
16.Secondary Outcome
Title Time to Onset DAS28 (CRP) Remission at Day 169
Hide Description The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of 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. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, "N" is number of participants analysed for this outcome measure.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 20 12
Median (90% Confidence Interval)
Unit of Measure: days
57.0
(29.0 to 112.0)
113.0
(57.0 to 141.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method Log Rank
Comments P-value was calculated using the Log rank test.
17.Secondary Outcome
Title Duration of DAS28 (CRP) Remission at Day 169
Hide Description The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of 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. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, "N" is number of participants analysed for this outcome measure.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 20 12
Mean (Standard Error)
Unit of Measure: days
105.0  (0.24) 69.6  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Weibull model
Comments P-value was calculated using an Weibull model.
18.Secondary Outcome
Title Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169
Hide Description The 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. The percentage of participants were calculated by logistic regression model method.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
19.0 17.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.795
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -1.7
Confidence Interval (2-Sided) 90%
-12.4 to 9.0
Estimation Comments 90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.
19.Secondary Outcome
Title Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169
Hide Description The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
18.9 7.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -11.7
Confidence Interval (2-Sided) 90%
-21.0 to -2.5
Estimation Comments 90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.
20.Secondary Outcome
Title Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
Hide Description The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
17.6 5.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -11.9
Confidence Interval (2-Sided) 90%
-20.6 to -3.1
Estimation Comments 90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.
21.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
Hide Description The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: percentage of participants
8.9 1.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value -7.5
Confidence Interval (2-Sided) 90%
-13.6 to -1.5
Estimation Comments 90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.
22.Secondary Outcome
Title Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
Hide Description Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Mean (Standard Error)
Unit of Measure: joint count
SJC: Baseline (n=68, 70) 14.49  (0.779) 14.07  (0.824)
SJC: Change at Day 169 (n=64, 64) -10.07  (0.777) -10.08  (0.747)
TJC: Baseline (n=68, 70) 24.93  (1.662) 25.04  (1.543)
TJC: Change at Day 169 (n=64, 64) -15.42  (1.457) -14.19  (1.399)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments Analysis reported for change from baseline in swollen joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.01
Confidence Interval (2-Sided) 90%
-1.33 to 1.32
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments Analysis reported for change from baseline in Tender joint count at Day 169.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.23
Confidence Interval (2-Sided) 90%
-1.31 to 3.77
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.
23.Secondary Outcome
Title Mean Change From Baseline in Patient Assessment of Pain at Day 169
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Mean (Standard Error)
Unit of Measure: millimeter (mm)
Baseline (n=68, 70) 66.93  (2.352) 69.81  (2.015)
Change at Day 169 (n=64, 64) -29.61  (3.843) -24.72  (3.727)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 4.89
Confidence Interval (2-Sided) 90%
-2.46 to 12.24
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.
24.Secondary Outcome
Title Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
Hide Description Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Mean (Standard Error)
Unit of Measure: mm
Baseline (n=68, 70) 67.57  (2.219) 68.53  (2.212)
Change at Day 169 (n=64, 64) -28.50  (3.773) -24.04  (3.671)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 4.46
Confidence Interval (2-Sided) 90%
-2.92 to 11.84
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.
25.Secondary Outcome
Title Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
Hide Description Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Mean (Standard Error)
Unit of Measure: centimeter (cm)
Baseline (n=68, 70) 6.89  (0.159) 7.04  (0.169)
Change at Day 169 (n=64, 64) -4.28  (0.317) -4.11  (0.307)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.16
Confidence Interval (2-Sided) 90%
-0.42 to 0.74
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.
26.Secondary Outcome
Title Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=68, 70) 1.58  (0.063) 1.59  (0.070)
Change at Day 169 (n=64, 64) -0.59  (0.081) -0.40  (0.078)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.18
Confidence Interval (2-Sided) 90%
0.03 to 0.34
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.
27.Secondary Outcome
Title Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline
Hide Description The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 64 64
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
0.5036
(344.0%)
0.5142
(100.9%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.752
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 90%
0.79 to 1.41
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.
28.Secondary Outcome
Title Erythrocyte Sedimentation Rate (ESR) at Day 169
Hide Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.
Time Frame Day 169
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Hide Analysis Population Description
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure. "n'' signifies participants evaluable for specified category for each arm, respectively.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Geometric Mean (Standard Deviation)
Unit of Measure: millimeter per hour (mm/h)
26.8  (21.0) 27.8  (20.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Golimumab 50 mg Alternating With Placebo, Mavrilimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.725
Comments [Not Specified]
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.84 to 1.30
Estimation Comments An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.
29.Secondary Outcome
Title Serum Concentrations of Mavrilimumab
Hide Description Serum concentrations after subcutaneous dose of mavrilimumab were calculated
Time Frame Baseline, Day 8, 15, 29, 85, 141, and 169
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Hide Analysis Population Description
The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here "n" signifies participants who were evaluable for the specified time point for each this arm respectively.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
Baseline (n=69)
0.00
(512.9%)
Day 8 (n=66)
2837.24
(49.1%)
Day 15 (n=67)
1084.43
(143.6%)
Day 29 (n=69)
2094.70
(58.9%)
Day 85 (n=67)
2886.71
(64.1%)
Day 141 (n=63)
1731.65
(79.3%)
Day 169 (n=64)
1701.13
(67.9%)
30.Secondary Outcome
Title Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab
Hide Description Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.
Time Frame Day 1 to Day 169
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Hide Analysis Population Description
The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Overall Number of Participants Analyzed 68 70
Measure Type: Number
Unit of Measure: participants
3 3
Time Frame Baseline up to Day 169
Adverse Event Reporting Description The safety population included all participants who received any amount of study medication.
 
Arm/Group Title Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Hide Arm/Group Description Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
All-Cause Mortality
Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/68 (4.41%)      2/70 (2.86%)    
Gastrointestinal disorders     
Gastroduodenitis  1  1/68 (1.47%)  1 0/70 (0.00%)  0
Peptic ulcer  1  1/68 (1.47%)  2 0/70 (0.00%)  0
Infections and infestations     
Pneumocystis jirovecii pneumonia  1  1/68 (1.47%)  1 0/70 (0.00%)  0
Investigations     
Hepatic enzyme increased  1  1/68 (1.47%)  1 0/70 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Parathyroid tumour benign  1  0/68 (0.00%)  0 1/70 (1.43%)  1
Nervous system disorders     
Vertebrobasilar insufficiency  1  0/68 (0.00%)  0 1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders     
Lung disorder  1  1/68 (1.47%)  1 0/70 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Golimumab 50 mg Alternating With Placebo Mavrilimumab 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/68 (42.65%)      36/70 (51.43%)    
Blood and lymphatic system disorders     
Leukocytosis  1  0/68 (0.00%)  0 2/70 (2.86%)  2
Gastrointestinal disorders     
Diarrhoea  1  0/68 (0.00%)  0 2/70 (2.86%)  2
Gastrooesophageal reflux disease  1  1/68 (1.47%)  1 1/70 (1.43%)  1
Nausea  1  1/68 (1.47%)  2 1/70 (1.43%)  1
General disorders     
Fatigue  1  2/68 (2.94%)  2 1/70 (1.43%)  1
Influenza like illness  1  0/68 (0.00%)  0 2/70 (2.86%)  3
Pyrexia  1  2/68 (2.94%)  2 0/70 (0.00%)  0
Infections and infestations     
Bronchitis  1  1/68 (1.47%)  1 1/70 (1.43%)  1
Ear infection  1  1/68 (1.47%)  1 1/70 (1.43%)  1
Herpes simplex  1  0/68 (0.00%)  0 2/70 (2.86%)  2
Influenza  1  1/68 (1.47%)  1 1/70 (1.43%)  1
Nasopharyngitis  1  1/68 (1.47%)  1 4/70 (5.71%)  4
Oral herpes  1  0/68 (0.00%)  0 2/70 (2.86%)  2
Pharyngitis  1  2/68 (2.94%)  2 1/70 (1.43%)  1
Rhinitis  1  2/68 (2.94%)  2 1/70 (1.43%)  1
Upper respiratory tract infection  1  2/68 (2.94%)  3 3/70 (4.29%)  4
Urinary tract infection  1  1/68 (1.47%)  1 2/70 (2.86%)  2
Viral upper respiratory tract infection  1  2/68 (2.94%)  2 3/70 (4.29%)  3
Investigations     
Alanine aminotransferase increased  1  2/68 (2.94%)  4 0/70 (0.00%)  0
Hepatic enzyme increased  1  2/68 (2.94%)  2 3/70 (4.29%)  3
Metabolism and nutrition disorders     
Dyslipidaemia  1  2/68 (2.94%)  2 0/70 (0.00%)  0
Hypercholesterolaemia  1  2/68 (2.94%)  2 0/70 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/68 (1.47%)  1 1/70 (1.43%)  1
Back pain  1  2/68 (2.94%)  3 2/70 (2.86%)  2
Rheumatoid arthritis  1  2/68 (2.94%)  7 1/70 (1.43%)  1
Tendonitis  1  2/68 (2.94%)  2 0/70 (0.00%)  0
Nervous system disorders     
Headache  1  2/68 (2.94%)  2 3/70 (4.29%)  3
Migraine  1  0/68 (0.00%)  0 2/70 (2.86%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/68 (0.00%)  0 2/70 (2.86%)  2
Skin and subcutaneous tissue disorders     
Ecchymosis  1  1/68 (1.47%)  1 1/70 (1.43%)  1
Vascular disorders     
Hypertension  1  1/68 (1.47%)  1 3/70 (4.29%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marius Albulescu, Associate Medical Director
Organization: MedImmune, LLC
Phone: 301-398-0000
EMail: albulescum@medimmune.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01715896    
Other Study ID Numbers: CD-IA-CAM-3001-1107
First Submitted: October 16, 2012
First Posted: October 29, 2012
Results First Submitted: March 8, 2016
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016