Interferon a2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT03209219
• Date of registration: 04/07/2017
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Interferon a2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
• Scientific title: Randomized Prospective Comparative Study of Interferon a2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis
• Date of first enrolment: June 30, 2017
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03209219
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China

Key inclusion & exclusion 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-a;

- 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Uveitis

Behçet Disease

Intervention(s)

Drug: Interferon Alfa-2A

Drug: Cyclosporine Pill

Primary Outcome(s)

Response rate [Time Frame: Within the 12-month follow-up period]

Complete remission rate [Time Frame: Within the 12-month follow-up period]

Tolerance rate [Time Frame: Within the 12-month follow-up period]

Secondary Outcome(s)

Duration of relapse-free [Time Frame: within the 12-month follow-up period]

Incidence of adverse effects [Time Frame: Within the 12-month follow-up period]

BCVA [Time Frame: Within the 12-month follow-up period]

BOS24 score [Time Frame: Within the 12-month follow-up period]

Glucocorticoid-sparing effect [Time Frame: Within the 12-month follow-up period]

Incidence of significant abnormal changes in vital signs or laboratory test results [Time Frame: Within the 12-month follow-up period]

Time to reach complete remission [Time Frame: Within the 12-month follow-up period]

Adverse effects profile [Time Frame: Within the 12-month follow-up period]

Secondary ID(s)

Z171100001017217

Source(s) of Monetary Support

Please refer to primary and secondary sponsors