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Sponsors and Collaborators: |
Tehran University of Medical Sciences Hoffmann-La Roche |
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Information provided by: | Tehran University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00664599 |
The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.
Condition | Intervention | Phase |
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Behcet's Syndrome |
Drug: Rituximab Drug: Cytotoxic Combination |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study) |
Enrollment: | 20 |
Study Start Date: | April 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Rituximab
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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).
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2: Active Comparator
Cytotoxics combination
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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.
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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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Rheumatology Research Center, Shariati Hospital | |
Tehran, Iran, Islamic Republic of, 14114 |
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 |
Responsible Party: | Rheumatology Research Center, Tehran University for Medical Sciences ( Fereydoun Davatchi, Head Rheumatology Research Center ) |
Study ID Numbers: | 132/12487 |
Study First Received: | April 20, 2008 |
Last Updated: | April 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00664599 History of Changes |
Health Authority: | Iran: Ethics Committee |
Ocular lesions, Visual Acuity, Retinal Vasculitis |
Mouth Diseases Uveitis, Anterior Panuveitis Uveal Diseases Vasculitis Immunologic Factors Skin Diseases Methylprednisolone Rituximab Eye Diseases Vascular Diseases Methylprednisolone acetate |
Prednisolone acetate Retinal Vasculitis Cyclophosphamide Behcet Syndrome Azathioprine Uveitis Prednisolone Methotrexate Stomatognathic Diseases Antirheumatic Agents Methylprednisolone Hemisuccinate |
Mouth Diseases Uveitis, Anterior Panuveitis Uveal Diseases Skin Diseases, Vascular Disease Vasculitis Immunologic Factors Skin Diseases Antineoplastic Agents Rituximab Eye Diseases |
Physiological Effects of Drugs Vascular Diseases Pharmacologic Actions Behcet Syndrome Pathologic Processes Uveitis Therapeutic Uses Syndrome Cardiovascular Diseases Stomatognathic Diseases Antirheumatic Agents |