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

NCT00167583 | Completed Phase 3 DMC

• 2 other identifiers: AKF 105-0-0BMBF-01KG0706
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet's Disease; Panuveitis; Posterior Uveitis; Retinal Vasculitis

Keywords

Ocular Behcet's disease; Panuveitis; Posterior Uveitis; Retinal vasculitis; Treatment; Interferon-alpha; Cyclosporin A

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (2)

A Cyclosporin A

ACTIVE COMPARATOR

Cyclosporin A

Drug: Cyclosporin A

B Interferon alpha

ACTIVE COMPARATOR

Interferon-alpha2a

Drug: Interferon-alpha2a

Interventions

Cyclosporin A DRUG

3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels

Also known as: Sandimmun neoral

A Cyclosporin A

Interferon-alpha2a DRUG

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

B Interferon alpha

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Department of Internal Medicine II and Department of Ophthalmology

Tübingen, D-72076, Germany

Location

Related Publications (7)

• 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. doi: 10.1016/j.semarthrit.2003.09.010.

  PMID: 15079763 BACKGROUND

• 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. doi: 10.1016/j.semarthrit.2003.09.005.

  PMID: 15079762 BACKGROUND

• 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. doi: 10.1136/bjo.87.4.423.

  PMID: 12642304 BACKGROUND

• 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. doi: 10.1136/bjo.84.12.1432g. No abstract available.

  PMID: 11186866 BACKGROUND

• 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. doi: 10.1136/ard.60.1.83. No abstract available.

  PMID: 11114291 BACKGROUND

• 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. doi: 10.1007/s00347-003-0927-7. German.

  PMID: 14991308 BACKGROUND

• 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.

  PMID: 16078350 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Behcet Syndrome; Panuveitis; Uveitis, Posterior; Retinal Vasculitis

Interventions

Cyclosporine; Interferon alpha-2

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Retinal Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• Ina Koetter, MD

  Tuebingen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 17, 2018

Record last verified: 2016-05

Locations

DE (1)