Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease

Tehran University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Behcet's Syndrome

Treatments: Drug: Rituximab; Drug: Cytotoxic Combination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00664599

132/12487

Details and patient eligibility

About

The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

1

Experimental group

Description:

Rituximab

Treatment:

Drug: Rituximab

2

Active Comparator group

Description:

Cytotoxics combination

Treatment:

Drug: Cytotoxic Combination