Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)

Study Overview
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Brief Summary
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The purpose of this study is to investigate if interferon-alpha2a is superior to the standard treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet's disease.

Detailed Description
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Behcet's disease is a multisystem vasculitis often involving ocular (retinal) blood vessels (in 70% of all cases). This form of uveitis or retinal vasculitis still leads to blindness in 25 to 50% of the patients irrespective of immunosuppressive treatment. The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard treatment (cyclosporin A (CSA)) for severe ocular (panuveitis, posterior uveitis, retinal vasculitis) Behçet's Disease (BD) and significantly improves visual prognosis and quality of health and life of the patients with ocular BD and is acting more rapidly than standard treatment. Furthermore, we want to evaluate if IFN-α induces long term remissions of ocular BD which can be maintained without further medical treatment. The patients are randomised into two treatment groups (IFN/CSA) and treated for one year according to an algorithm which adapts dosages to clinical course. A crossover from one treatment arm to the other is planned in case of inefficacy.

Official Title
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Phase III Study of Recombinant Human Interferon-alpha2a Versus Cyclosporin A for the Treatment of Ocular Behcet's Disease - a National,Randomised, Single-masked Controlled Trial (INCYTOB)

Conditions
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Behcet's Disease, Panuveitis, Posterior Uveitis, Retinal Vasculitis

Intervention / Treatment
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* Drug: Cyclosporin A
* Drug: Interferon-alpha2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Behçet's disease fulfilling the International Study Group Criteria with active pan- or posterior uveitis (according to the posterior uveitis scoring system) or retinal vasculitis and active disease according to the Behcet's Disease activity scoring system. Exclusion Criteria: Previous treatment with interferon-α or cyclosporin A Pregnancy, breast feeding women, malignancy Renal impairment (creatinine > 1.5 mg/dl) Uncontrolled hypertension or diabetes Depression or other psychic disorders(also history of depression) History of acute or chronic inflammatory joint or autoimmune disease Organ or bone marrow transplant recipient, cardiac failure > NYHAIII Acute liver disease with SGPT 2x above normal White blood cell count < 3500/mm3 Platelet count < 100000/mm3 Hgb < 8.5g/dl Body weight <45 kg Alcohol abuse or drug abuse Mental impairment Uncooperative attitude

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A Cyclosporin A<br>Cyclosporin A | Drug: Cyclosporin A<br>* 3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels<br>* Other names: Sandimmun neoral;|
| Active Comparator: B Interferon alpha<br>Interferon-alpha2a | Drug: Interferon-alpha2a<br>* 3-6 million iU per day sc., augmented to up to 9 if necessary, later reduced (according to clinical response) to 3 x 3 million iU /week.<br>* Other names: Roferon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) |  | 2 years | 
| Time to improvement and remission |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory values for inflammatory activity (monthly) |  | 2 years | 
| Number of switches from one treatment to the other |  | 2 years | 
| Quality of life for patients with low vision (monthly) |  | 2 years | 
| Number of ocular and non-ocular relapses (1 year, 2 years) |  | 2 years | 
| Duration of the treatment-free period (second year) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular Behcet's disease, Panuveitis, Posterior Uveitis, Retinal vasculitis, Treatment, Interferon-alpha, Cyclosporin A