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

Overview

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

Full Title of Study: “Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet’s Disease (Pilot Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2008

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

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Rituximab
  • Active Comparator: 2
    • Cytotoxics combination

Clinical Trial Outcome Measures

Primary Measures

  • Visual acuity
    • Time Frame: 6 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tehran University of Medical Sciences
  • Collaborator
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
  • Overall Official(s)
    • Fereydoun Davatchi, MD, Study Chair, Rheumatology Research Center, Tehran University for Medical Sciences
    • Hormoz Shams, MD, Principal Investigator, Rheumatology Research Center, Tehran University for Medical Sciences
    • Mozhgan Rezaipoor, MD, Principal Investigator, Rheumatology Research Center, Tehran University for Medical Sciences
    • Farhad Shahram, MD, Principal Investigator, Rheumatology Research Center, Tehran University for Medical Sciences
    • Cheyda Chams-Davatchi, MD, Principal Investigator, Rheumatology Research Center, Tehran University for Medical Sciences
    • Bahar Sadeghi, MD, Principal Investigator, Rheumatology Research Center, Tehran University for Medical Sciences

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