Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis (NCT03209219) | Clinical Trial Compass
CompletedPhase 3
Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
China28 participantsStarted 2017-06-30
Plain-language summary
Brief summary: This study compares the long-term efficacy and safety of interferon (IFN) α2a and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral glucocorticosteroid in patients with refractory Behçet's uveitis (BDU). Half of the participants will receive IFNα2a while the other half will receive CsA.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Refractory BDU patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis;
* The patient should be on ≥10mg/d oral prednisone or equivalent with at least one of the following IMT agents: cyclophosphamide≥50mg/d, CsA≥100mg/d, azathioprine≥50mg/d, methotrexate≥15mg/w, mycophenolate≥1000mg/d, tacrolimus≥2mg/d.
Exclusion Criteria:
* Previous treatment with interferon-α;
* Pregnancy, breast feeding women;
* Malignancy;
* Renal impairment (creatinine \> 1.5 mg/dl);
* Uncontrolled hypertension or diabetes;
* Depression or other psychic disorders;
* History of acute or chronic inflammatory joint or autoimmune disease;
* Patients with severe extra-ocular involvement other than oral/genital ulcer and skin involvement;
* Organ or bone marrow transplant recipient, cardiac failure \> NYHA III;
* Acute liver disease with ALT or SGPT 2x above normal;
* White blood cell count \< 3500/mm\^3;
* Platelet count \< 100000/mm\^3;
* Hgb \< 8.5g/dl;
* T-SPOT TB: ≥200 SFCs per 10\^6 PBMC;
* Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of large dose corticosteroids;
* Previous intolerance to CsA;
* Other severe ocular diseases or intraocular surgery within 3 months;
* Media opacity precluding a clear view of the fundus;
* Positive screen test for HBV, HCV, HIV infection or syphilis;
* Body weight \<45 kg;
* Alcohol abuse or drug …