A Phase 3 interventional study of Cyclosporin A and Interferon-alpha2a in Behcet's Disease, Panuveitis and Posterior Uveitis, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by University Hospital Tuebingen · Phase 3, Interventional, and Treatment
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.
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.
136 studies on the registry are indexed under Behcet Syndrome; 42 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 70 interventional studies indexed under Behcet Syndrome.
Browse Behcet Syndrome studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cyclosporin A
Drug: Cyclosporin A
Interferon-alpha2a
Drug: Interferon-alpha2a
3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
Also known as: Sandimmun neoral
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.
Also known as: 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
Plan to share: Undecided
The record gives a start of Nov 2004, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclosporine · Interferon alpha-2
University Hospital Tuebingen →