A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: rituximab [MabThera/Rituxan]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00422383

WA17044

Details and patient eligibility

About

This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Enrollment

378 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients >=18 years of age;
RA for >=6 months;
receiving outpatient treatment;
inadequate response to methotrexate, having received 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;
inflammatory joint disease other than RA, or other systemic autoimmune disorder;
diagnosis of juvenile arthritis, or RA before the age of 16;
previous treatment with >1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.