Trial information
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Status: No longer recruiting
Protocol number: ML20538
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect of MabThera on treatment response in patients with rheumatoid arthritis who have had an inadequate response to previous TNF inhibition.
Brief summary: This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 20.
Study phase: IV
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][MabThera/Rituxan]
Primary outcome: 1. DAS 24 Time frame: Week 24
Key secondary outcomes: 1. ACR 20/50/70 and HAQ Time frame: Weeks 2, 6, 16, 24, 36 and 48
2. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- diagnosed RA for >=3 months prior to first administration of study medication;
- inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
- if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.
Exclusion criteria:
- other chronic inflammatory diseases;
- use of parental corticosteroids within 4 weeks prior to screening;
- severe heart failure, or severe, uncontrolled cardiac disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2007
Trial registration date: 01/18/2007
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Hungary
