SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01126541

ML19895

Details and patient eligibility

About

This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a moderate or good response will be randomized to receive re-treatment with either 1 or 2 additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients >18 years of age
• RA for >=6 months
• Receiving outpatient treatment
• Ongoing treatment with methotrexate for >=3 months, stable for >=1 month
• Inadequate response or intolerance to etanercept, infliximab or adalimumab

Exclusion criteria

• Previous treatment with MabThera
• Concurrent treatment with any anti TNF-alfa therapy or biologic therapy
• Previous treatment with any investigational cell-depleting therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

A

Experimental group

Description:

1000 mg IV rituximab

Treatment:

Drug: rituximab

B

Experimental group

Description:

2 x 1000 mg IV rituximab

Treatment:

Drug: rituximab