Behcet's Disease Clinical Trial
— INCYTOBOfficial 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)
Verified date | May 2016 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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-a 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Internal Medicine II and Department of Ophthalmology | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Deuter CM, Kötter I, Günaydin I, Zierhut M, Stübiger N. [Ocular involvement in Behçet's disease: first 5-year-results for visual development after treatment with interferon alfa-2a]. Ophthalmologe. 2004 Feb;101(2):129-34. German. — View Citation
Kötter I, Aepinus C, Graepler F, Gärtner V, Eckstein AK, Stübiger N, Kaskas B, Zierhut M, Bültmann B, Kandolf R, Kanz L. HHV8 associated Kaposi's sarcoma during triple immunosuppressive treatment with cyclosporin A, azathioprine, and prednisolone for ocular Behçet's disease and complete remission of both disorders with interferon alpha. Ann Rheum Dis. 2001 Jan;60(1):83-6. — View Citation
Kotter I, Deuter C, Stubiger N, Zierhut M. Interferon-a (IFN-a) application versus tumor necrosis factor-a antagonism for ocular Behçet's disease: focusing more on IFN. J Rheumatol. 2005 Aug;32(8):1633; author reply 1634. — View Citation
Kötter I, Günaydin I, Zierhut M, Stübiger N. The use of interferon alpha in Behçet disease: review of the literature. Semin Arthritis Rheum. 2004 Apr;33(5):320-35. Review. — View Citation
Kötter I, Vonthein R, Zierhut M, Eckstein AK, Ness T, Günaydin I, Grimbacher B, Blaschke S, Peter HH, Stübiger N. Differential efficacy of human recombinant interferon-alpha2a on ocular and extraocular manifestations of Behçet disease: results of an open 4-center trial. Semin Arthritis Rheum. 2004 Apr;33(5):311-9. — View Citation
Kötter I, Zierhut M, Eckstein AK, Vonthein R, Ness T, Günaydin I, Grimbacher B, Blaschke S, Meyer-Riemann W, Peter HH, Stübiger N. Human recombinant interferon alfa-2a for the treatment of Behçet's disease with sight threatening posterior or panuveitis. Br J Ophthalmol. 2003 Apr;87(4):423-31. — View Citation
Stuebiger N, Koetter I, Zierhut M. Complete regression of retinal neovascularization after therapy with interferon alfa in Behçet's disease. Br J Ophthalmol. 2000 Dec;84(12):1437-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) | 2 years | ||
Primary | Time to improvement and remission | 2 years | ||
Secondary | Laboratory values for inflammatory activity (monthly) | 2 years | ||
Secondary | Number of switches from one treatment to the other | 2 years | ||
Secondary | Quality of life for patients with low vision (monthly) | 2 years | ||
Secondary | Number of ocular and non-ocular relapses (1 year, 2 years) | 2 years | ||
Secondary | Duration of the treatment-free period (second year) | 2 years |
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