Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB) (INCYTOB)
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|ClinicalTrials.gov Identifier: NCT00167583|
Recruitment Status : Unknown
Verified March 2009 by University Hospital Tuebingen.
Recruitment status was: Recruiting
First Posted : September 14, 2005
Last Update Posted : July 28, 2010
|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)|
|Estimated Enrollment :||100 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|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||December 2012|
Active Comparator: A
Drug: Cyclosporin A
3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
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.
- 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
|Contact: Ina Koetter, MDemail@example.com|
|Contact: Christoph Deuter, MDfirstname.lastname@example.org|
|Department of Internal Medicine II and Department of Ophthalmology||Recruiting|
|Tuebingen, Germany, D-72076|
|Contact: Ina Koetter, MD +49-7071-2985138 email@example.com|
|Contact: Christoph Deuter, MD firstname.lastname@example.org|
|Principal Investigator: Ina Koetter, MD|
|Sub-Investigator: Christoph Deuter, MD|
|Sub-Investigator: Manfred Zierhut, MD|
|Sub-Investigator: Ilhan Guenaydin, MD|
|Principal Investigator:||Ina Koetter, MD||Tuebingen University Hospital|