Phase 3
Completed N=302
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
Source: ClinicalTrials.gov NCT02079532 ↗Enrolled (actual)
302
Serious AEs
11.9%
Results posted
Jun 2015
Primary outcomePrimary: Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28) — -1.56 scores on a scale
Summary
This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28) |
-1.56 | — |
| SECONDARY DAS28 Score |
5.87; 4.57; 4.17; 4.30 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate |
59.1; 68.0; 64.6 | — |
| SECONDARY Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24 |
21.6 | — |
| SECONDARY Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24 |
11.7 | — |
| SECONDARY Percentage of Participants Achieving a Response By EULAR Category |
45.4; 44.3; 44.0; 13.7; 23.7; 20.6 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
1.60; 1.43; 1.33; 1.32 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score |
23.81; 20.87; 18.92; 18.53 | — |
| SECONDARY Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS) |
30.97; 34.24; 35.92; 36.36; 40.88; 43.50 | — |
| SECONDARY SF-36 Domain Scores |
39.04; 43.60; 44.64; 47.37; 25.94; 37.24 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70) |
38.8; 47.8; 46.4; 13.7; 19.9; 24.4 | — |
| SECONDARY Swollen Joint Count (SJC) |
10.01; 5.16; 4.22; 4.70 | — |
| SECONDARY Tender Joint Count (TJC) |
12.62; 7.53; 6.04; 6.41 | — |
| SECONDARY Physician's Global Assessment of Disease Activity |
63.99; 39.20; 33.03; 35.75 | — |
| SECONDARY Patient's Assessment of Disease Activity |
63.49; 46.19; 41.25; 41.47 | — |
| SECONDARY Patient's Assessment of Pain |
62.78; 47.30; 42.11; 41.76 | — |
| SECONDARY C-Reactive Protein (CRP) |
1.82; 1.60; 1.81; 1.31; 1.21; 1.30 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
30.20; 28.07; 30.61; 24.85; 22.28; 23.64 | — |
| SECONDARY Rheumatoid Factor (RF) |
178.23; 109.84; 88.22; 87.52 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-75 years of age;
- rheumatoid arthritis for >=6 months;
- previous inadequate response to a single anti-TNF alpha inhibitor;
- methotrexate at a stable dose range 7.5-25 mg/week.
Exclusion Criteria
- other chronic inflammatory articular disease or systemic autoimmune disease;
- previous treatment with MabThera or intolerance to MabThera;
- corticosteroids>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;
Data sourced from ClinicalTrials.gov (NCT02079532). 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. Informational only — not medical advice.