Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Cyclosporine; Cyclosporins; Interferon alpha-2; Interferon-alpha; Interferons

Criteria

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 abuse;

• Mental impairment;

• Uncooperative attitude.