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

Sponsor
Hoffmann-La Roche
Study ID
NCT01126541
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    Arm A: 1000 mg IV (one infusion) every 2 months \\nArm B: 2 x 1000 mg IV (2 infusions) every 2 months

Study Details

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.

Key Dates

Start date
Sep 30, 2006
Status verified
Sep 2014
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    1000 mg IV rituximab
  • Experimental: B
    2 x 1000 mg IV rituximab

Primary Outcome Measure

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) Area Under the Curve (AUC) at Week 104 [ Time Frame: Week 104 ]

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