Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

Uveitis Clinical Trial

Official title:

Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209219
• Other study ID #: Z171100001017217
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behçet Disease
• Behcet Syndrome
• Uveitis

Intervention

Drug:
• Interferon Alfa-2A
3×10^6 IU, subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter
• Cyclosporine Pill
100mg, oral, bid

Locations

Country	Name	City	State
China	Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Percentage of participants who achieve complete remission or partial remission	Within the 12-month follow-up period
Primary	Complete remission rate	Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis	Within the 12-month follow-up period
Primary	Tolerance rate	Percentage of participants who adhere to the treatment without severe side effects	Within the 12-month follow-up period
Secondary	Time to reach complete remission	The time from the therapy initiation to a complete absence of ocular inflammation for complete responders	Within the 12-month follow-up period
Secondary	Duration of relapse-free	The duration between the therapy initiation to the relapse for partial responders and nonresponders	within the 12-month follow-up period
Secondary	BCVA	Changes of best-corrected visual acuity	Within the 12-month follow-up period
Secondary	BOS24 score	Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)	Within the 12-month follow-up period
Secondary	Glucocorticoid-sparing effect	Changes of corticosteroid dosage	Within the 12-month follow-up period
Secondary	Incidence of adverse effects	Incidence of adverse effects	Within the 12-month follow-up period
Secondary	Incidence of significant abnormal changes in vital signs or laboratory test results	Incidence of significant abnormal changes in vital signs or laboratory test results	Within the 12-month follow-up period
Secondary	Adverse effects profile	Types of drug adverse effects	Within the 12-month follow-up period