drugset / Trial / NCT00422942
A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This single arm study will investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15) + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile of MabThera after treatment and retreatment will also be investigated. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.
Timeline
- Start
- 2006-01
- Primary completion
- 2010-06
- Completion
- 2010-06
Outcome
Outcome not reported
Stopped (Enrollment): “Study was terminated after enrollment of 3 participants due to recruitment difficulties.”
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 |