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

Phase 2

Completed

• Conditions: Behcet's Syndrome
• Interventions: Drug: Rituximab; Drug: Cytotoxic Combination

• Registration Number: NCT00664599
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-04
• Study First Submitted: 2008-04-20
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Last Update Submitted: 2008-04-27
• Last Update Posted: 2008-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rituximab	Rituximab
2	Cytotoxic Combination	Cytotoxics combination

Primary Outcome Measures

Name	Time	Method
Visual acuity	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rheumatology Research Center, Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of