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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rituximab |
|
| 2 | Active Comparator | Cytotoxics combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Infusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory index for posterior uveitis | 6 months | |
| Inflammatory index for retinal vasculitis, especially for edema | 6 months | |
| Total Adjusted Disease Activity Index (TADAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fereydoun Davatchi, MD | Rheumatology Research Center, Tehran University for Medical Sciences | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Research Center, Shariati Hospital | Tehran | Tehran Province | 14114 | Iran |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 18, 2010 | |
| Reset | Sep 10, 2010 | |
| Release | Nov 19, 2010 | |
| Reset | Dec 14, 2010 | |
| Release | Feb 20, 2011 | |
| Reset | Mar 21, 2011 | |
| Release | Jun 2, 2012 | |
| Reset | Jul 5, 2012 | |
| Release | Nov 4, 2015 | |
| Reset | Dec 9, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 18, 2010 | Sep 10, 2010 | |||
| Nov 19, 2010 |
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| D031300 | Retinal Vasculitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Cytotoxic Combination | Drug | Pulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily. |
|
|
| 6 months |
| Dec 14, 2010 |
| Feb 20, 2011 | Mar 21, 2011 |
| Jun 2, 2012 | Jul 5, 2012 |
| Nov 4, 2015 | Dec 9, 2015 |
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D012164 | Retinal Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |