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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone
To test in a randomized single blind control trial the efficacy of Etanercept in patients with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with Methotrexate and prednisolone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept-MTX-Prednisolone | Active Comparator | Methotrexate + Prednisolone + Etanercept |
|
| B, MTX-Prednisolone | Other | Methotrexate + Prednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept, Methotrexate, Prednisolone | Drug | In: Arm A, Etanercept-MTX-Prednisolone: Etanercept 50 mg weekly (subcutaneous injection) for 12 months. Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses. In Arm B: Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fereydoun Davatchi, MD | Contact | (98-21) 8802-6956 | fddh@davatchi.net | |
| Bahar Sadeghi, MD | Contact | (98-21) 8820-6956 | bahar@bahars.net |
| Name | Affiliation | Role |
|---|---|---|
| Fereydoun Davatchi, MD | Rheumatology Research Center, Medical Sciences/University of Teheran | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital) | Recruiting | Tehran | 14114 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Melikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-α blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400 | ||
| 12918769 | Background | Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behcet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. doi: 10.1007/0-306-48382-3_118. No abstract available. | |
| Background | Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145 | ||
| Background | Davatchi F, Shams H, Nadji A, Jamshidi AR, Akhlaghi M, Sadeghi Abdollahi B, Ziaie N, Akbarian M, Gharibdoost F. Management of ocular manifestations of Behcet's Disease: outcome with cytotoxic drugs. APLAR Journal of Rheumatology 2005; 8: 119-123 |
| Label | URL |
|---|---|
| Rheumatology Research Center, Medical Sciences/University of Tehran | View source |
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| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| D014603 | Uveal Diseases |
| D014605 | Uveitis |
| D031300 | Retinal Vasculitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D008727 | Methotrexate |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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|
|
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |