drugset / Trial / NCT01000610
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NaSingle-groupOpen-labelTreatment
Summary
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc 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 target sample size is \<50
Timeline
- Start
- 2008-03-17
- Primary completion
- 2012-05-16
- Completion
- 2012-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Methotrexate | Small molecule | 10 mg | Oral |
| Background | Methotrexate | Small molecule | 25 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | 100 mg | Intravenous |