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

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Sep 9, 2005

Keywords

ClinConnect Summary

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 m...

Gender

ALL

Eligibility 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