Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB) (NCT00167583) | Clinical Trial Compass
CompletedPhase 3
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)
Germany37 participantsStarted 2004-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years)