Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease
- Sponsor
- Tehran University of Medical Sciences
- Study ID
- NCT00664599
- Phase
- PHASE2
- Status
- Completed
Conditions
- Behcet's Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGInfusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).
- Cytotoxic Combination — DRUGPulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.
Study Details
The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.
Key Dates
- Start date
- Apr 30, 2006
- Status verified
- Apr 2008
- Primary completion
- Jan 31, 2008
- Completion
- Jan 31, 2008
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1Rituximab
- Active Comparator: 2Cytotoxics combination
Primary Outcome Measure
Visual acuity [ Time Frame: 6 months ]