Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
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Purpose
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
| Condition | Intervention |
|---|---|
|
Behcet Syndrome Uveal Disease |
Drug: Etanercept, Methotrexate, Prednisolone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease |
- Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis [ Time Frame: One Year ] [ Designated as safety issue: No ]
- DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index [ Time Frame: One Year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Etanercept-MTX-Prednisolone
Methotrexate + Prednisolone + Etanercept
|
Drug: Etanercept, Methotrexate, Prednisolone
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. Other Name: Enbrel
|
|
B, MTX-Prednisolone
Methotrexate + Prednisolone
|
Drug: Etanercept, Methotrexate, Prednisolone
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. Other Name: Enbrel
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
- Active posterior uveitis and/or retinal vasculitis
Exclusion Criteria:
- Visual acuity inferior to 1/10 on Snellen chart
- Being under cytotoxic drugs or having received them in the past 2 months
- Not being able to follow the one year treatment and the regular follow ups
Contacts and Locations| Contact: Fereydoun Davatchi, MD | (98-21) 8802-6956 | fddh@davatchi.net |
| Contact: Bahar Sadeghi, MD | (98-21) 8820-6956 | bahar@bahars.net |
| Iran, Islamic Republic of | |
| Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital) | Recruiting |
| Tehran, Iran, Islamic Republic of, 14114 | |
| Contact: Fereydoun Davatchi, MD (98-21)8802-6956 fddh@davatchi.net | |
| Contact: Bahar Sadeghi, MD (98-21)8802-6956 bahar@bahars.net | |
| Principal Investigator: Fereydoun Davatchi, MD | |
| Principal Investigator: Farhad Shahram, MD | |
| Principal Investigator: Hormoz Shams, MD | |
| Sub-Investigator: Abdolhadi Nadji, MD | |
| Sub-Investigator: Bahar Sadeghi, MD | |
| Sub-Investigator: Massoomeh Akhlaghi, MD | |
| Sub-Investigator: Tahereh Faezi, MD | |
| Study Chair: | Fereydoun Davatchi, MD | Rheumatology Research Center, Medical Sciences/University of Teheran |
More Information
Additional Information:
Publications:
| Responsible Party: | Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00931957 History of Changes |
| Other Study ID Numbers: | 860241-5807 |
| Study First Received: | June 30, 2009 |
| Last Updated: | November 19, 2010 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Tehran University of Medical Sciences:
|
Etanercept Behcet's syndrome Behcet's Disease |
Ocular Lesions Uveitis Retinal Vasculitis |
Additional relevant MeSH terms:
|
Behcet Syndrome Uveal Diseases Mouth Diseases Stomatognathic Diseases Uveitis, Anterior Panuveitis Uveitis Eye Diseases Vasculitis Vascular Diseases Cardiovascular Diseases Skin Diseases, Vascular Skin Diseases Methotrexate TNFR-Fc fusion protein |
Prednisolone Methylprednisolone Hemisuccinate Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013