Status:
COMPLETED
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Behcet's Disease
Panuveitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00167583
Start Date
November 1 2004
End Date
December 1 2014
Last Update
May 17 2018
Active Locations (1)
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1
Department of Internal Medicine II and Department of Ophthalmology
Tübingen, Germany, D-72076