A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis
Both
Rheumatoid Arthritis
Trial Information
A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Area under the curve (AUC) of the Disease Activity Score (DAS)
Outcome Time Frame:
From baseline up to Month 24
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ML19895
NCT ID:
NCT01126541
Start Date:
September 2006
Completion Date:
November 2011
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
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