Overview

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.