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Therapeutic Areas: Rheumatology | Musculoskeletal
Disease Category: Rheumatoid Arthritis
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 359.
Study Phase: III
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Active
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Rheumatoid Arthritis
Intervention Type: Drug
Intervention Name: rituximab [MabThera/Rituxan]
Primary Outcome: 1. Percentage of patients with ACR20 response Time frame: Week 48
Key Secondary Outcomes: 1. Percentage of patients with ACR50 and ACR70 response Time frame: Week 48
2. Change in DAS28, SF-36, FACIT-fatigue assessment from baseline Time frame: Week 48
3. EULAR response rates Time frame: Week 48
4. AEs, laboratory parameters and acute phase reactants Time frame: 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
Accepts Healthy Volunteers: No
Anticipated Start Date: February, 2006
Trial Registration Date: 03/10/2006
Date Last Updated: 06/15/2009
Link To Trial Results
Research Site:
Located In:
Torino 10100
Italy
Phone: 973-235-5000 or 800-526-6367
View Google Map
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