Trial information
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD and/or anti-TNF Therapy.
Status: Recruiting
Protocol number: ML18606
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the safety and effect on disease activity of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to prior treatment with DMARDs and/or one anti-TNF alpha agent
Brief summary: This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to prior treatment with DMARDs and/or one anti-TNF alpha agent. Patients will be treated with MabThera (1000mg i.v.) on days 1 and 15; they may receive concomitant treatment with DMARDs, corticosteroids, NSAIDs and analgesics throughout the study period. After week 48, eligible patients may receive re-treatment with MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 150.
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. Adverse events, laboratory parameters Time frame: Throughout study
Key secondary outcomes: 1. Categorical DAS responders Time frame: Week 24
2. Change in bone density Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- rheumatoid arthritis;
- inadequate response to previous or current treatment with DMARDs and/or 1 anti-TNF agent.
Exclusion criteria:
- rheumatic autoimmune disease or inflammatory joint disease other than RA;
- concurrent treatment with an anti-TNF alpha therapy;
- active infection or significant uncontrolled disease or malignancy.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2005
Trial registration date: 07/19/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Israel
- Ashkelon
- Beer Sheva
- Haifa
- Holon
- Jerusalem
- Kfar Saba
- Nahariya
- Nazareth
- Petah Tikva
- Rehovot
- Rishon Lezion
- Tel Aviv
