A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: methotrexate

Drug: rituximab [MabThera/Rituxan]

Study type

Interventional

Funder types

Industry

Identifiers

NCT02097745

WA17531

Details and patient eligibility

About

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Enrollment

341 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients 18-80 years of age with active RA;
patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
eligible for re-treatment, based on clinical symptoms;
patients of reproductive potential must be using reliable contraceptive methods.

Exclusion criteria

patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
development of any new contraindications to receiving MabThera;
women who are pregnant or breast-feeding.