Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB) (INCYTOB)
Recruitment status was: Recruiting
Drug: Cyclosporin A
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Time to improvement and remission [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Laboratory values for inflammatory activity (monthly) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of switches from one treatment to the other [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Quality of life for patients with low vision (monthly) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of ocular and non-ocular relapses (1 year, 2 years) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Duration of the treatment-free period (second year) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167583
|Department of Internal Medicine II and Department of Ophthalmology|
|Tuebingen, Germany, D-72076|
|Principal Investigator:||Ina Koetter, MD||Tuebingen University Hospital|