Status:
COMPLETED
Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Behcet's Syndrome
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.
Detailed Description
To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily prednisolone.
Eligibility Criteria
Inclusion
- Behcet's Disease fulfilling the new International Criteria for Behcet's Disease
- Having active ocular lesions (posterior and/or retinal vasculitis)
- Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg
Exclusion
- Visual acuity less than 1/10 on Snellen chart
- Antecedent of allergic reaction to any component of the therapeutic regimen
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00664599
Start Date
April 1 2006
End Date
January 1 2008
Last Update
April 30 2008
Active Locations (1)
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1
Rheumatology Research Center, Shariati Hospital
Tehran, Tehran Province, Iran, 14114