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

Purpose

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	Intervention	Phase
Behcet's Disease Panuveitis Posterior Uveitis Retinal Vasculitis	Drug: Cyclosporin A Drug: Interferon-alpha2a	Phase 3

Study Type:	Interventional
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)

Resource links provided by NLM:

Genetics Home Reference related topics: Behçet disease

MedlinePlus related topics: Behcet's Syndrome Vasculitis

Drug Information available for: Interferon Cyclosporine Interferon Alfa-2a

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
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)

Arms	Assigned Interventions
Active Comparator: A Cyclosporin A	Drug: Cyclosporin A 3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
Experimental: B 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167583

Contacts

Contact: Ina Koetter, MD	+49-7071-2985138	ina.koetter@med.uni-tuebingen.de
Contact: Christoph Deuter, MD		christoph.deuter@med.uni-tuebingen.de

Locations

Germany
Department of Internal Medicine II and Department of Ophthalmology	Recruiting
Tuebingen, Germany, D-72076
Contact: Ina Koetter, MD +49-7071-2985138 ina.koetter@med.uni-tuebingen.de
Contact: Christoph Deuter, MD christoph.deuter@med.uni-tuebingen.de
Principal Investigator: Ina Koetter, MD
Sub-Investigator: Christoph Deuter, MD
Sub-Investigator: Manfred Zierhut, MD
Sub-Investigator: Ilhan Guenaydin, MD

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Ina Koetter, MD

Tuebingen University Hospital

More Information

Additional Information:

Homepage with informations on Behcet`s Disease and on the study protocol , treatment algorithms and centres (in German) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Kotter I, Gunaydin I, Zierhut M, Stubiger N. The use of interferon alpha in Behcet disease: review of the literature. Semin Arthritis Rheum. 2004 Apr;33(5):320-35. Review.

Kotter I, Vonthein R, Zierhut M, Eckstein AK, Ness T, Gunaydin I, Grimbacher B, Blaschke S, Peter HH, Stubiger N. Differential efficacy of human recombinant interferon-alpha2a on ocular and extraocular manifestations of Behcet disease: results of an open 4-center trial. Semin Arthritis Rheum. 2004 Apr;33(5):311-9.

Kotter I, Zierhut M, Eckstein AK, Vonthein R, Ness T, Gunaydin I, Grimbacher B, Blaschke S, Meyer-Riemann W, Peter HH, Stubiger N. Human recombinant interferon alfa-2a for the treatment of Behcet'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 Behcet's disease. Br J Ophthalmol. 2000 Dec;84(12):1437-8. No abstract available.

Kotter I, Aepinus C, Graepler F, Gartner V, Eckstein AK, Stubiger N, Kaskas B, Zierhut M, Bultmann B, Kandolf R, Kanz L. HHV8 associated Kaposi's sarcoma during triple immunosuppressive treatment with cyclosporin A, azathioprine, and prednisolone for ocular Behcet's disease and complete remission of both disorders with interferon alpha. Ann Rheum Dis. 2001 Jan;60(1):83-6. No abstract available.

Deuter CM, Kotter I, Gunaydin I, Zierhut M, Stubiger N. [Ocular involvement in Behcet's disease: first 5-year-results for visual development after treatment with interferon alfa-2a] Ophthalmologe. 2004 Feb;101(2):129-34. German.

Kotter I, Deuter C, Stubiger N, Zierhut M. Interferon-a (IFN-a) application versus tumor necrosis factor-a antagonism for ocular Behcet's disease: focusing more on IFN. J Rheumatol. 2005 Aug;32(8):1633; author reply 1634. No abstract available.

Responsible Party:	Prof. Ina Koetter, University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00167583 History of Changes
Other Study ID Numbers:	AKF 105-0-0, BMBF-01KG0706
Study First Received:	September 9, 2005
Last Updated:	July 26, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

Ocular Behcet`s disease
Panuveitis
Posterior Uveitis
Retinal vasculitis

Treatment
Interferon-alpha
Cyclosporin A

Additional relevant MeSH terms:

Behcet Syndrome
Panuveitis
Uveitis
Chorioretinitis
Uveitis, Posterior
Vasculitis
Retinal Vasculitis
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular

Skin Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Cyclosporins
Cyclosporine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013