Behcet's Syndrome
Conditions
Keywords
Ocular lesions, Visual Acuity, Retinal Vasculitis
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.
Interventions
DRUGRituximab
Infusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).
DRUGCytotoxic Combination
Pulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.
Sponsors
Hoffmann-La Roche
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Visual acuity less than 1/10 on Snellen chart * Antecedent of allergic reaction to any component of the therapeutic regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory index for posterior uveitis | 6 months |
| Inflammatory index for retinal vasculitis, especially for edema | 6 months |
| Total Adjusted Disease Activity Index (TADAI) | 6 months |
Countries
Iran
Outcome results
None listed