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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Cyclosporine; Cyclosporins; Interferon alpha-2; Interferon-alpha; Interferons

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