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

University Hospital Tuebingen37 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Behcet's Disease Panuveitis Posterior Uveitis Retinal Vasculitis

Interventions

Cyclosporin ADRUG

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

Interferon-alpha2aDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Internal Medicine II and Department of Ophthalmology

Tübingen, Germany

Outcomes

Primary Outcomes

Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years)

Time frame: 2 years

Time to improvement and remission

Time frame: 2 years

Secondary Outcomes

Laboratory values for inflammatory activity (monthly)

Time frame: 2 years

Number of switches from one treatment to the other

Time frame: 2 years

Quality of life for patients with low vision (monthly)

Time frame: 2 years

Number of ocular and non-ocular relapses (1 year, 2 years)

Time frame: 2 years

Duration of the treatment-free period (second year)

Time frame: 2 years

Data from ClinicalTrials.gov

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