Phase 2
N=326
A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01706926 ↗Enrolled (actual)
326
Serious AEs
3.7%
Results posted
Sep 2016
Primary outcome: Primary: Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85 — 5.78; 5.73; 5.91; 5.67 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mavrilimumab 30 mg (Biological); Mavrilimumab 100 mg (Biological); Mavrilimumab 150 mg (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85 |
5.78; 5.73; 5.91; 5.67; -0.68; -1.37 | <0.001 sig |
| PRIMARY Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 |
24.7; 50.6; 61.2; 73.4 | <0.001 sig |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
46.9; 50.6; 42.4; 54.4; 1.2; 4.9 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) |
2; 4; 4; 3; 1; 1 | — |
| SECONDARY Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169 |
97.6; 98.5; 96.0; 89.3; 0.0; 0.0 | — |
| SECONDARY Dyspnea Score at Day 169 |
0.38; 0.22; 0.32; 0.28 | — |
| SECONDARY Oxygen Saturation Level at Day 169 |
97.4; 97.4; 97.4; 97.3 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 |
12.3; 28.4; 25.9; 40.5 | 0.013 sig |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 |
3.7; 12.3; 10.6; 13.9 | 0.079 |
| SECONDARY Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169 |
13.25; 29.04; 30.24; 40.72 | 0.009 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169 |
65.4; 30.9; 28.2; 19.0; 25.9; 35.8 | <0.001 sig |
| SECONDARY Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169 |
4.9; 21.0; 17.6; 19.0; 8.6; 33.3 | 0.004 sig |
| SECONDARY Mean Change From Baseline in Swollen and Tender Joint Count at Day 169 |
14.44; 17.80; 16.82; 15.72; -4.97; -10.65 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Patient Assessment of Pain at Day 169 |
62.16; 62.65; 63.58; 62.35; -15.20; -23.14 | 0.045 sig |
| SECONDARY Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169 |
64.86; 63.79; 63.71; 62.39; -20.21; -21.06 | 0.837 |
| SECONDARY Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169 |
6.60; 6.60; 6.81; 6.42; -2.39; -3.81 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169 |
1.63; 1.52; 1.58; 1.58; -0.29; -0.37 | 0.479 |
| SECONDARY Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169 |
1.2971; 0.8784; 0.5197; 0.5856 | 0.017 sig |
| SECONDARY Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169 |
0.89; 0.67; 0.62; 0.58 | 0.003 sig |
| SECONDARY Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169 |
1.2; 6.2; 2.4; 5.1 | 0.210 |
| SECONDARY Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169 |
1.2; 6.2; 3.5; 7.6 | 0.210 |
| SECONDARY Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169 |
0.0; 3.7; 1.2; 1.3 | 0.245 |
| SECONDARY Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169 |
26.75; 28.91; 28.45; 27.82; 4.53; 5.72 | 0.463 |
| SECONDARY Serum Concentrations of Mavrilimumab |
0.00; 0.00; 0.00; 617.49; 3563.31; 6087.06 | — |
| SECONDARY Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit |
2.5; 16.0; 3.5; 0.0 | — |
Summary
The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).
Eligibility Criteria
Inclusion Criteria
- A diagnosis of adult onset Rheumatoid Arthritis (RA) in line with the protocol
- Moderately active disease in line with the protocol
- A pre-defined number of swollen joints in line with the protocol
- Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
- No evidence of respiratory disease.
Exclusion Criteria
- A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA
- A history of, or current, inflammatory joint disease other than RA
- Previous treatment with the investigational drug
- Discontinuation of a biologic DMARD due to lack of efficacy
- Non-compliant concurrent medications
- Non-compliance with medical history criteria.
Data sourced from ClinicalTrials.gov (NCT01706926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.