Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

NCT ID: NCT03209219

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2021-01-31

Brief 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.

Detailed Description

Detailed description: Both CsA and IFNα2a have been shown to be effective for long-term control of BDU, however, randomized prospective comparative studies are scarce, particularly in East Asian populations. Our preliminary data gave us the impression that IFNα2a might be more effectiveness than CsA in long-term control of refractory BDU, and this study aimed to compare their effectiveness and safety profiles in a well-designed prospective study. Refractory BDU is defined as relapse of posterior or pan- uveitis with at least 10mg daily prednisone (or equivalent) and one traditional immunomodulatory treatment (IMT) agents. The acute attack is controlled with large dose oral corticosteroid (60mg daily prednisone) for 4 weeks, and then the patients are randomly assigned to the IFN arm and the CsA arm, in which patients are treated with IFNα2a (3×10^6 IU qd for 4 weeks and qod thereafter) and CsA (100mg bid), respectively, along with a fixed tapering regimen of corticosteroid. Patients were followed up until relapse, or for 12 months.

Conditions

Behçet Disease; Uveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interferon Alpha 2A

Patients are treated with IFNα2a 3×10\^IU α2a by subcutaneous injection or intramuscular injection daily for 4 weeks, and followed by every other day there after.

Group Type: EXPERIMENTAL

Interferon Alfa-2A

Intervention Type: DRUG

3×10\^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter

Cyclosporine

Patients are treated with oral CsA 100mg twice daily.

Group Type: ACTIVE_COMPARATOR

Cyclosporine Pill

Intervention Type: DRUG

100mg， oral, bid

Interventions

Interferon Alfa-2A

3×10\^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter

Intervention Type: DRUG

Cyclosporine Pill

100mg， oral, bid

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meifen Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Z171100001017217

Identifier Type: -

Identifier Source: org_study_id