Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB) (INCYTOB)
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|ClinicalTrials.gov Identifier: NCT00167583|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Behcet's Disease Panuveitis Posterior Uveitis Retinal Vasculitis||Drug: Cyclosporin A Drug: Interferon-alpha2a||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: A Cyclosporin A
Drug: Cyclosporin A
3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
Other Name: Sandimmun neoral
Active Comparator: B Interferon alpha
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.
Other Name: Roferon
- Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) [ Time Frame: 2 years ]
- Time to improvement and remission [ Time Frame: 2 years ]
- Laboratory values for inflammatory activity (monthly) [ Time Frame: 2 years ]
- Number of switches from one treatment to the other [ Time Frame: 2 years ]
- Quality of life for patients with low vision (monthly) [ Time Frame: 2 years ]
- Number of ocular and non-ocular relapses (1 year, 2 years) [ Time Frame: 2 years ]
- Duration of the treatment-free period (second year) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167583
|Department of Internal Medicine II and Department of Ophthalmology|
|Tuebingen, Germany, D-72076|
|Principal Investigator:||Ina Koetter, MD||Tuebingen University Hospital|