A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272908

ML20381

Details and patient eligibility

About

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, 18-80 years of age
• Moderate to severe active rheumatoid arthritis
• Inadequate response to a single previous or current treatment with an anti-TNF agent
• Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks

Exclusion criteria

• Previous treatment with MabThera
• Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
• Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
• Active infection, or history of serious or chronic infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Single arm

Experimental group

Treatment:

Drug: rituximab