Overview

A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)

Status:
Terminated

Trial end date:
2010-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Methotrexate
Rituximab