Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A Cyclosporin 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 Names:
|
| Active Comparator: B Interferon alpha Interferon-alpha2a |
Drug: Interferon-alpha2a
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 Names:
|
Outcome Measures
Primary Outcome Measures
- Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) [2 years]
- Time to improvement and remission [2 years]
Secondary Outcome Measures
- Laboratory values for inflammatory activity (monthly) [2 years]
- Number of switches from one treatment to the other [2 years]
- Quality of life for patients with low vision (monthly) [2 years]
- Number of ocular and non-ocular relapses (1 year, 2 years) [2 years]
- Duration of the treatment-free period (second year) [2 years]
Eligibility Criteria
Criteria
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-α 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Internal Medicine II and Department of Ophthalmology | Tuebingen | Germany | D-72076 |
Sponsors and Collaborators
- University Hospital Tuebingen
Investigators
- Principal Investigator: Ina Koetter, MD, Tuebingen University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- AKF 105-0-0
- BMBF-01KG0706