Trial Outcomes & Findings for A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis (NCT NCT01715896)
NCT ID: NCT01715896
Last Updated: 2016-10-31
Results Overview
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.
COMPLETED
PHASE2
215 participants
Day 169
2016-10-31
Participant Flow
Overall, 215 participants were screened, of which 77 participants were considered as screen failures and 138 participants were randomized and completed in the study.
Participant milestones
| Measure |
Golimumab 50 Milligram (mg) Alternating With Placebo
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.
|
Mavrilimumab 100 mg
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 Study
STARTED
|
68
|
70
|
|
Overall Study
COMPLETED
|
65
|
59
|
|
Overall Study
NOT COMPLETED
|
3
|
11
|
Reasons for withdrawal
| Measure |
Golimumab 50 Milligram (mg) Alternating With Placebo
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.
|
Mavrilimumab 100 mg
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 Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Other
|
2
|
5
|
Baseline Characteristics
A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Golimumab 50 Milligram (mg) Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
|
65.6 percentage of participants
|
62.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
|
43.4 percentage of participants
|
34.8 percentage of participants
|
PRIMARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
|
25.9 percentage of participants
|
16.1 percentage of participants
|
PRIMARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169
|
29.0 percentage of participants
|
17.4 percentage of participants
|
PRIMARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169
|
69.0 percentage of participants
|
58.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 169Population: The safety population included all participants who received any amount of study medication.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Investigational-product-related TEAE
|
11 participants
|
12 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
29 participants
|
36 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Severe TEAE
|
3 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Acute TEAEs
|
7 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Acute Severe TEAE
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Investigational-product-related TESAE
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 169Population: The safety population included all participants who received any amount of investigational product.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Leukocytosis
|
0 participants
|
2 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Neutropenia
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Anaemia of chronic disease
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Alanine aminotransferase increased
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood parathyroid hormone increased
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Gamma-glutamyltransferase increased
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hepatic enzyme increased
|
2 participants
|
3 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Dyslipidaemia
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypercholesterolaemia
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hyperglycaemia
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hyperlipidaemia
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypertriglyceridaemia
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Urinalysis
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 169Population: The safety population included all participants who received any amount of study medication.
Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypertension
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Pyrexia
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 85 and 169Population: 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.
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).
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: FEV1 > 20% RD and AV < 80% PR (n=64, 64)
|
4 participants
|
1 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: FVC > 20% RD (n=64, 64)
|
2 participants
|
1 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: FEV1 > 20% RD (n=64, 63)
|
1 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: FEV1 > 20% RD (n=64, 64)
|
4 participants
|
1 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: FEV1 > 20% RD and AV < 80% PR (n=64, 63)
|
1 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: FEV6 > 20% RD (n=54, 55)
|
1 participants
|
1 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: FEV6 > 20% RD (n=54, 56)
|
4 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: FEV6 > 20% RD and AV < 80% PR (n=54, 55)
|
0 participants
|
1 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: FEV6 > 20% RD and AV < 80% PR (n=54, 56)
|
2 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: FVC > 20% RD (n=64, 63)
|
0 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: FVC > 20% RD and AV < 80% PR (n=64, 63)
|
0 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: FVC > 20% RD and AV < 80% PR (n=64, 64)
|
2 participants
|
1 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: DLCO > 15-20% RD (n=18, 21)
|
1 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: DLCO > 15-20% RD (n=22, 23)
|
0 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 85: DLCO > 20% RD (n=18, 21)
|
1 participants
|
0 participants
|
|
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Day 169: DLCO > 20% RD (n=22, 23)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=64 Participants
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.
|
Mavrilimumab 100 mg
n=63 Participants
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.
|
|---|---|---|
|
Dyspnea Score at Day 169
|
0.34 units on a scale
Standard Deviation 0.81
|
0.42 units on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: 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
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169
Baseline (n=68, 70)
|
5.72 units on a scale
Standard Deviation 0.83
|
5.82 units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169
Day 169 (n=62, 62)
|
-2.40 units on a scale
Standard Deviation 1.42
|
-2.11 units on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline up to Day 169Population: 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.
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).
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169
|
40.49 units on a scale
Standard Error 5.406
|
33.06 units on a scale
Standard Error 5.199
|
SECONDARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
American College of Rheumatology (ACR) Hybrid Score at Day 169
|
49.99 units on a scale
Interval -9.0 to 98.2
|
41.66 units on a scale
Interval -1.0 to 90.3
|
SECONDARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (CRP) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (CRP) \>=3.2 to less than or equal to (=\<) 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (CRP) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (CRP) \>5.1.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
No response
|
12 participants
|
16 participants
|
|
Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
Moderate response
|
28 participants
|
35 participants
|
|
Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
Good response
|
28 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
Low Disease Activity
|
28 participants
|
20 participants
|
|
Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
DAS28 (CRP) Remission
|
20 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=20 Participants
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.
|
Mavrilimumab 100 mg
n=12 Participants
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.
|
|---|---|---|
|
Time to Onset DAS28 (CRP) Remission at Day 169
|
57.0 days
Interval 29.0 to 112.0
|
113.0 days
Interval 57.0 to 141.0
|
SECONDARY outcome
Timeframe: Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=20 Participants
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.
|
Mavrilimumab 100 mg
n=12 Participants
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.
|
|---|---|---|
|
Duration of DAS28 (CRP) Remission at Day 169
|
105.0 days
Standard Error 0.24
|
69.6 days
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169
|
19.0 percentage of participants
|
17.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169
|
18.9 percentage of participants
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
|
17.6 percentage of participants
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
|
8.9 percentage of participants
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
TJC: Baseline (n=68, 70)
|
24.93 joint count
Standard Error 1.662
|
25.04 joint count
Standard Error 1.543
|
|
Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
SJC: Baseline (n=68, 70)
|
14.49 joint count
Standard Error 0.779
|
14.07 joint count
Standard Error 0.824
|
|
Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
SJC: Change at Day 169 (n=64, 64)
|
-10.07 joint count
Standard Error 0.777
|
-10.08 joint count
Standard Error 0.747
|
|
Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
TJC: Change at Day 169 (n=64, 64)
|
-15.42 joint count
Standard Error 1.457
|
-14.19 joint count
Standard Error 1.399
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Patient Assessment of Pain at Day 169
Baseline (n=68, 70)
|
66.93 millimeter (mm)
Standard Error 2.352
|
69.81 millimeter (mm)
Standard Error 2.015
|
|
Mean Change From Baseline in Patient Assessment of Pain at Day 169
Change at Day 169 (n=64, 64)
|
-29.61 millimeter (mm)
Standard Error 3.843
|
-24.72 millimeter (mm)
Standard Error 3.727
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
Baseline (n=68, 70)
|
67.57 mm
Standard Error 2.219
|
68.53 mm
Standard Error 2.212
|
|
Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
Change at Day 169 (n=64, 64)
|
-28.50 mm
Standard Error 3.773
|
-24.04 mm
Standard Error 3.671
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
Baseline (n=68, 70)
|
6.89 centimeter (cm)
Standard Error 0.159
|
7.04 centimeter (cm)
Standard Error 0.169
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
Change at Day 169 (n=64, 64)
|
-4.28 centimeter (cm)
Standard Error 0.317
|
-4.11 centimeter (cm)
Standard Error 0.307
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
Baseline (n=68, 70)
|
1.58 units on a scale
Standard Error 0.063
|
1.59 units on a scale
Standard Error 0.070
|
|
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
Change at Day 169 (n=64, 64)
|
-0.59 units on a scale
Standard Error 0.081
|
-0.40 units on a scale
Standard Error 0.078
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=64 Participants
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.
|
Mavrilimumab 100 mg
n=64 Participants
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.
|
|---|---|---|
|
Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline
|
0.5036 ratio
Geometric Coefficient of Variation 344.0
|
0.5142 ratio
Geometric Coefficient of Variation 100.9
|
SECONDARY outcome
Timeframe: Day 169Population: 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.
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.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Day 169
|
26.8 millimeter per hour (mm/h)
Standard Deviation 21.0
|
27.8 millimeter per hour (mm/h)
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 29, 85, 141, and 169Population: 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.
Serum concentrations after subcutaneous dose of mavrilimumab were calculated
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=70 Participants
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.
|
Mavrilimumab 100 mg
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.
|
|---|---|---|
|
Serum Concentrations of Mavrilimumab
Baseline (n=69)
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 512.9
|
—
|
|
Serum Concentrations of Mavrilimumab
Day 8 (n=66)
|
2837.24 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49.1
|
—
|
|
Serum Concentrations of Mavrilimumab
Day 15 (n=67)
|
1084.43 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 143.6
|
—
|
|
Serum Concentrations of Mavrilimumab
Day 29 (n=69)
|
2094.70 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.9
|
—
|
|
Serum Concentrations of Mavrilimumab
Day 85 (n=67)
|
2886.71 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 64.1
|
—
|
|
Serum Concentrations of Mavrilimumab
Day 141 (n=63)
|
1731.65 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 79.3
|
—
|
|
Serum Concentrations of Mavrilimumab
Day 169 (n=64)
|
1701.13 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 67.9
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 169Population: 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.
Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.
Outcome measures
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 Participants
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.
|
Mavrilimumab 100 mg
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab
|
3 participants
|
3 participants
|
Adverse Events
Golimumab 50 mg Alternating With Placebo
Mavrilimumab 100 mg
Serious adverse events
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 participants at risk
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.
|
Mavrilimumab 100 mg
n=70 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroduodenitis
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Gastrointestinal disorders
Peptic ulcer
|
1.5%
1/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Investigations
Hepatic enzyme increased
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
Other adverse events
| Measure |
Golimumab 50 mg Alternating With Placebo
n=68 participants at risk
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.
|
Mavrilimumab 100 mg
n=70 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
General disorders
Fatigue
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
General disorders
Influenza like illness
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 3 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
General disorders
Pyrexia
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Ear infection
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Influenza
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
5.7%
4/70 • Number of events 4 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Pharyngitis
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Rhinitis
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
2/68 • Number of events 3 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
4.3%
3/70 • Number of events 4 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
4.3%
3/70 • Number of events 3 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
2/68 • Number of events 4 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Investigations
Hepatic enzyme increased
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
4.3%
3/70 • Number of events 3 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
2/68 • Number of events 3 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.9%
2/68 • Number of events 7 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
0.00%
0/70 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Nervous system disorders
Headache
|
2.9%
2/68 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
4.3%
3/70 • Number of events 3 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/68 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
2.9%
2/70 • Number of events 2 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
1.4%
1/70 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
|
Vascular disorders
Hypertension
|
1.5%
1/68 • Number of events 1 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
4.3%
3/70 • Number of events 3 • Baseline up to Day 169
The safety population included all participants who received any amount of study medication.
|
Additional Information
Marius Albulescu, Associate Medical Director
MedImmune, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER