Phase 3
Completed N=335
A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies
Source: ClinicalTrials.gov NCT02097745 ↗Enrolled (actual)
335
Serious AEs
44.4%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response — 67.5; 74.9; 73.9; 67.4 Percentage of participants
Summary
This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response |
67.5; 74.9; 73.9; 67.4; 69.9; 72.8 | — |
| SECONDARY Change From Baseline in the Disease Activity Score 28 (DAS28) |
-2.32; -2.77; -3.01; -3.05; -3.15; -2.96 | — |
| SECONDARY Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission |
17.2; 8.9; 27.9; 15.1; 36.8; 18.8 | — |
| SECONDARY Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses |
17.1; 64.8; 18.1; 27.5; 64.3; 8.1 | — |
| SECONDARY Change From Baseline in the American College of Rheumatology n (ACRn) Response |
32.04; 39.25; 39.89; 37.71; 37.59; 35.53 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
-0.51; -0.54; -0.56; -0.55; -0.60; -0.55 | — |
| SECONDARY Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey |
7.383; 5.550; 6.018; 5.746; 6.206; 4.777 | — |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score |
10.790; 6.390; 7.075; 6.770; 8.030; 5.429 | — |
| SECONDARY Percentage of Participants With no Radiographic Progression From Baseline to Year 5 |
21.5; 32.4 | — |
| SECONDARY Change From Baseline in the Total Genant-modified Sharp Score at Year 5 |
5.446; 3.202 | — |
| SECONDARY Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5 |
3.101; 1.880 | — |
| SECONDARY Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5 |
2.344; 1.322 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5 |
-0.408; -0.540 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients 18-80 years of age with active RA;
- patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
- eligible for re-treatment, based on clinical symptoms;
- patients of reproductive potential must be using reliable contraceptive methods.
Exclusion Criteria
- patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
- current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
- development of any new contraindications to receiving MabThera;
- women who are pregnant or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT02097745). 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.