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

Sponsor
Tehran University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00664599
Collaborator
Hoffmann-La Roche (Industry)
20
Enrollment
1
Location
2
Arms
21
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Rituximab

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).
Other Names:
  • Mabthera
  • Rituxan

    		•
    Active Comparator: 2

    Cytotoxics combination

    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.
    Other Names:
  • Cytoxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [6 months]

    Secondary Outcome Measures

    1. Inflammatory index for posterior uveitis [6 months]

    2. Inflammatory index for retinal vasculitis, especially for edema [6 months]

    3. Total Adjusted Disease Activity Index (TADAI) [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rheumatology Research Center, Shariati Hospital Tehran Iran, Islamic Republic of 14114

    Sponsors and Collaborators

    • Tehran University of Medical Sciences
    • Hoffmann-La Roche

    Investigators

    • Study Chair: Fereydoun Davatchi, MD, Rheumatology Research Center, Tehran University for Medical Sciences
    • Principal Investigator: Hormoz Shams, MD, Rheumatology Research Center, Tehran University for Medical Sciences
    • Principal Investigator: Mozhgan Rezaipoor, MD, Rheumatology Research Center, Tehran University for Medical Sciences
    • Principal Investigator: Farhad Shahram, MD, Rheumatology Research Center, Tehran University for Medical Sciences
    • Principal Investigator: Cheyda Chams-Davatchi, MD, Rheumatology Research Center, Tehran University for Medical Sciences
    • Principal Investigator: Bahar Sadeghi, MD, Rheumatology Research Center, Tehran University for Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00664599
    Other Study ID Numbers:
    • 132/12487
    First Posted:
    Apr 23, 2008
    Last Update Posted:
    Apr 30, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    Ocular lesions, Visual Acuity, Retinal Vasculitis
    Additional relevant MeSH terms:
    Behcet Syndrome
    Rituximab

    Study Results

    No Results Posted as of Apr 30, 2008