Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB)

Behcet's Disease Clinical Trial

— INCYTOB  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167583
• Other study ID #: AKF 105-0-0
• Secondary ID: BMBF-01KG0706
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Est. completion date: December 2014

Study information

• Verified date: May 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Disease
• Panuveitis
• Posterior Uveitis
• Retinal Vasculitis
• Uveitis
• Uveitis, Posterior
• Vasculitis

Intervention

Drug:
• Cyclosporin A
3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
• 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.

Locations

Country	Name	City	State
Germany	Department of Internal Medicine II and Department of Ophthalmology	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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

Outcome

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

External Links

•   Homepage with informations on Behcet`s Disease and on the study protocol , treatment algorithms and centres (in German)