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

U

University Hospital Tuebingen

Status and phase

Completed
Phase 3

Conditions

Posterior Uveitis
Retinal Vasculitis
Panuveitis
Behcet's Disease

Treatments

Drug: Interferon-alpha2a
Drug: Cyclosporin A

Study type

Interventional

Funder types

Other

Identifiers

NCT00167583
AKF 105-0-0
BMBF-01KG0706 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

37 participants in 2 patient groups

A Cyclosporin A
Active Comparator group
Description:
Cyclosporin A
Treatment:
Drug: Cyclosporin A
B Interferon alpha
Active Comparator group
Description:
Interferon-alpha2a
Treatment:
Drug: Interferon-alpha2a

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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