Trial information
SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on anti-TNF alfa Therapy.
Status: Recruiting
Protocol number: ML19895
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: 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)
Brief summary: This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis who have previously experienced an inadequate response or intolerance to etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000mg 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 1000mg iv MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 320.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. AUC of the DAS
Key secondary outcomes: 1. Efficacy: ACR 20/50/70, Eular response, change from baseline in SF-12, HAQ-DI, Pain VAS, Fatigue VAS, MOS score. Safety: AEs, leucocyte count, IgG, IgM, IgA.
Inclusion criteria:
- adult patients >18 years of age;
- RA for >=6 months;
- receiving outpatient treatment;
- ongoing treatment with MTX 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2006
Trial registration date: 06/16/2006
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Abbeville
- Agen
- Aix en Provence
- Amiens
- Belfort
- Berck
- Bobigny
- Bordeaux
- Boulogne-Billancourt
- Brest
- Caen
- Cahors
- Clermont-Ferrand
- Corbeil-Essonnes
- Echirolles
- La Roche Sur Yon
- Le Kremlin-Bicetre
- Libourne
- Lievin
- Lille
- Limoges
- Lomme
- Lyon
- Marseille
- Montivilliers
- Montpellier
- Nantes
- Nice
- Paris
- Pau
- Perpignan
- Pessac
- Pierre Benite
- Poitiers
- Rennes
- Rouen
- Saint-Etienne
- Strasbourg
- Toulon
- Toulouse
- Valence
- Valenciennes
- Vandoeuvre-Les-Nancy
- Vannes
