Trial information
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
Status: No longer recruiting
Protocol number: WA17044
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study to evaluate the effect of various re-treatment regimens of MabThera in combination with methotrexate on treatment response in rheumatoid arthritis patients with an inadequate response to methotrexate.
Brief summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 375.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: Percentage of patients with an ACR 20 response. Timeframe: Week 48.
Key secondary outcomes: Proportion of patients with ACR 50 & ACR 70. Timeframe: Week 48. Change in DAS28, SF-36, FACIT-Fatigue assessment from baseline. Timeframe: Week 48. EULAR response rates. Timeframe: Week 48. AEs, laboratory parameters, & acute phase reactants. Timeframe: Throughout study.
Inclusion criteria:
- adult patients >=18 years of age;
- RA for >=6 months;
- receiving outpatient treatment;
- inadequate response to methotrexate, having received and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.
Exclusion criteria:
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
- inflammatory joint disease other than RA, or other systemic autoimmune disorder;
- diagnosis of juvenile arthritis, or RA before the age of 16;
- previous treatment with >1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2006
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Coffs Harbour
- Maroochydore
- Melbourne
- Sydney
Belgium
Brazil
Canada
- Penticton, BC
- Victoria, BC
- Winnipeg, MB
- London, ON
- Newmarket, ON
- Toronto, ON
- Trois-Rivieres, QC
China
Finland
France
- Bordeaux
- Le Mans
- Montpellier
- Nice
- Paris
- Rouen
Germany
- Bad Nauheim
- Hamburg
- Heidelberg
- Herne
- Köln
- Osnabrück
- Ratingen
Hungary
Italy
- Arenzano
- Coppito
- Ferrara
- Genova
- Palermo
- Pieve Di Coriano
- Pisa
- Prato
- Reggio Emilia
- Siena
- Torino
- Valeggio Sul Mincio
Netherlands
New Zealand
- Auckland
- Christchurch
- Timaru
Slovakia
South Africa
- Cape Town
- Pretoria
- Soweto
Spain
- Barcelona
- Gijon
- Leon
- Madrid
- Sevilla
Taiwan
- Kaohsiung
- Taichung
- Taoyuan
Thailand
- Bangkok
- Chiang Mai
- Khon Kaen
United Kingdom
- Birmingham
- Cambridge
- London
- Londonderry
- Middlesborough
- Northampton
- Nottingham
- Reading
- Truro
- Wigan
- Wirral
