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

Roche

Status and phase

Terminated

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Methotrexate

Drug: rituximab [MabThera/Rituxan]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00422942

WA19078

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.