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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Tehran University of Medical Sciences

Current Primary Outcome: Visual acuity [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Inflammatory index for posterior uveitis [ Time Frame: 6 months ]
  • Inflammatory index for retinal vasculitis, especially for edema [ Time Frame: 6 months ]
  • Total Adjusted Disease Activity Index (TADAI) [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Tehran University of Medical Sciences

Dates:
Date Received: April 20, 2008
Date Started: April 2006
Date Completion:
Last Updated: April 27, 2008
Last Verified: April 2008