Trial information
A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.
Status: No longer recruiting
Protocol number: ML21081
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Pilot study to evaluate the effect of Mabthera in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis.
Brief summary: This single arm study will measure the effect of MabThera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of 10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals. Target sample size is 10.
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]
Primary outcome: 1. Synovitis, bone marrow edema and erosions, measured by MRI. Time frame: 6 months
Key secondary outcomes: 1. Ritchie articular index, HAQ, DAS 28, laboratory markers of disease activity. Time frame: Weeks 4, 12 and 24 after MabThera cycle
2. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-75 years of age;
- rheumatoid arthritis for >=3 months and <=10 years;
- inadequate response to methotrexate (12.5-25mg/week) for >=3 months;
- evidence of erosive disease and/or clinical synovitis in a signal joint.
Exclusion criteria:
- autoimmune rheumatic diseases other than RA;
- surgical operations on bones/joints in 12 weeks prior to baseline visit;
- concomitant treatment with biologic agents;
- previous treatment with more than one biologic agent approved for RA, or with cell-depleting therapies.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 07/19/2007
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
