Phase 3
Completed N=15
A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Source: ClinicalTrials.gov NCT02006706 ↗Enrolled (actual)
15
Serious AEs
14.3%
Results posted
Nov 2014
Primary outcomePrimary: Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24 — 2.98 score on a scale — p=<0.001
Summary
This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24 |
2.98 | <0.001 sig |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) |
1.91; 1.05 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-80 years of age;
- rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
- active disease;
- DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.
Exclusion Criteria
- autoimmune disease other than rheumatoid arthritis;
- bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
- concurrent treatment with any DMARD or antiTNF-alfa;
- intra-articular or parenteral corticosteroids within 4 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT02006706). 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.