A Study of Re-Treatment With 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/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502840

ML19071

Details and patient eligibility

About

This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Enrollment: 193 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit;
• eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).

Exclusion criteria

• patients who have withdrawn from treatment in ML19070 pre-week 16;
• patients with a previous response in DAS28 <0.6 to MabThera after week 16;
• concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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193 participants in 1 patient group

1

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]