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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
First received
Last updated
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
Health authority
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

Study Design


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
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