An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Hoffmann-La Roche0 sites15 target enrollmentOctober 2007

ConditionsRheumatoid Arthritis

Interventionsrituximab [MabThera/Rituxan]methotrexate

Drugsrituximab [MabThera/Rituxan]methotrexate

Overview

Phase: Phase 4
Intervention: rituximab [MabThera/Rituxan]
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 15
Primary Endpoint: Percentage of Participants With an Adverse Event (AE)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

November 2010

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•adult patients, \>=18 years of age;
•receiving out-patient treatment;
•experienced an inadequate response to previous or current treatment with methotrexate.

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;
•previous treatment with any cell-depleting therapies.

Arms & Interventions

1

Intervention: rituximab [MabThera/Rituxan]

1

Intervention: methotrexate

Outcomes

Primary Outcomes

Percentage of Participants With an Adverse Event (AE)

Time Frame: Week 104

Secondary Outcomes

Disease Activity Score Based on 28-Joint Count (DAS28)(Day 1 and Week 24)
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category(Screening, Day 1, and Weeks 24 and 104)
Percentage of Participants With Changes in Bone Density(Screening, Weeks 48 and 104)