Trial information
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior anti-TNF Therapy.
Status: No longer recruiting
Protocol number: ML20381
Sponsor: Roche Canada
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the safety of MabThera, and its effect on treatment response, in patients with rheumatoid arthritis, following inadequate response to one prior anti-TNF agent.
Brief summary: This study will evaluate the safety and effectiveness of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 120.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Overall incidence of AEs for 48 weeks after initial treatment.
Key secondary outcomes: 1. Safety: Incidence of AEs after re-treatment with MabThera; lab tests. Efficacy: ACR 20/50/70, EULAR response rates, at weeks 4,12,24,36 and 48; changes from baseline in DAS28, ACR, HAQ, FACIT.
Inclusion criteria:
- adult patients, 18-80 years of age;
- moderate to severe active rheumatoid arthritis;
- inadequate response to a single previous or current treatment with an anti-TNF agent;
- methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks.
Exclusion criteria:
- previous treatment with MabThera;
- use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept);
- concurrent treatment with any DMARD other than methotrexate;
- active infection, or history of serious or chronic infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 07/19/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Edmonton, AB
- Kelowna, BC
- Victoria, BC
- Winnipeg, MB
- St John'S
- Hamilton, ON
- Mississauga, ON
- Nepean, ON
- Ottawa, ON
- Thunder Bay, ON
- Toronto, ON
- Windsor, ON
- Laval, QC
- Montreal, QC
- Quebec City, QC
- Sainte-Foy, QC
- Sherbrooke, QC
- St-Eustache, QC
- Trois-Rivieres, QC
Sweden
- Boras
- Falun
- Goeteborg
- Jonkoping
- Kalmar
- Karlskrona
- Lulea
- Malmoe
- Oskarstroem
- Skoevde
- Stockholm
- Sundsvall
