Phase 4
Completed N=15
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT00934648 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With an Adverse Event (AE) — 26.7 percentage of participants
Summary
This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) |
26.7 | — |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28) |
5.79; 4.41 | — |
| SECONDARY Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category |
0; 22.2; 77.8; 0; 33.3; 66.7 | — |
| SECONDARY Percentage of Participants With Changes in Bone Density |
20; 46.7; 0; 33.3; 6.7; 13.3 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- receiving out-patient treatment;
- experienced an inadequate response to previous or current treatment with methotrexate.
Exclusion Criteria
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
- history of, or current, inflammatory joint disease other than RA;
- previous treatment with any cell-depleting therapies.
Data sourced from ClinicalTrials.gov (NCT00934648). 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.