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

Behcet's Syndrome Clinical Trial

Official title:

Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664599
• Other study ID #: 132/12487
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2008
• Last updated: April 27, 2008
• Start date: April 2006
• Est. completion date: January 2008

Study information

• Verified date: April 2008
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Syndrome

Intervention

Drug:
• Rituximab
Infusion 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
Pulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rheumatology Research Center, Shariati Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Hoffmann-La Roche

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		6 months
Secondary	Inflammatory index for posterior uveitis		6 months
Secondary	Inflammatory index for retinal vasculitis, especially for edema		6 months
Secondary	Total Adjusted Disease Activity Index (TADAI)		6 months