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:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Methotrexate
Rituximab
Criteria
Inclusion Criteria:

- adult patients 18-80 years of age;

- RA for >=3 months;

- receiving outpatient treatment;

- failed treatment with >=1 DMARD (but not anti TNF or other biologic therapy);

- inadequate response to methotrexate, having taken and tolerated it for >=12 weeks,
with a stable dose for >=4 weeks.

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, or other systemic
autoimmune disorder;

- diagnosis of RA before the age of 16;

- bone/joint surgery within 12 weeks of study;

- prior use of anti-TNF or other biologic therapy, an anti-alpha 4 integrin, or any
cell-depleting therapies.