A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: rituximab [MabThera]

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079532

ML19070

Details and patient eligibility

About

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Enrollment: 302 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years of age;
• rheumatoid arthritis for >=6 months;
• previous inadequate response to a single anti-TNF alpha inhibitor;
• methotrexate at a stable dose range 7.5-25 mg/week.

Exclusion criteria

• other chronic inflammatory articular disease or systemic autoimmune disease;
• previous treatment with MabThera or intolerance to MabThera;
• corticosteroids>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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302 participants in 1 patient group

MabThera (Rituximab)

Experimental group

Treatment:

Drug: rituximab [MabThera]