Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

• ClinicalTrials.gov Identifier: NCT03209219
• Recruitment Status: Completed
• First Posted: July 6, 2017
• Last Update Posted: February 23, 2021
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Meifen Zhang, Peking Union Medical College Hospital

Tracking Information

• First Submitted Date: July 4, 2017
• First Posted Date: July 6, 2017
• Last Update Posted Date: February 23, 2021
• Actual Study Start Date: June 30, 2017
• Actual Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 20, 2021)

• Response rate [ Time Frame: Within the 12-month follow-up period ]
  Percentage of participants who achieve complete remission or partial remission
• Complete remission rate [ Time Frame: Within the 12-month follow-up period ]
  Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis
• Tolerance rate [ Time Frame: Within the 12-month follow-up period ]
  Percentage of participants who adhere to the treatment without severe side effects

Original Primary Outcome Measures (submitted: July 5, 2017)

relapse rate [ Time Frame: within the 12-month follow-up period ]

relapse of posterior or pan-uveitis

Current Secondary Outcome Measures (submitted: February 20, 2021)

• Time to reach complete remission [ Time Frame: Within the 12-month follow-up period ]
  The time from the therapy initiation to a complete absence of ocular inflammation for complete responders
• Duration of relapse-free [ Time Frame: within the 12-month follow-up period ]
  The duration between the therapy initiation to the relapse for partial responders and nonresponders
• BCVA [ Time Frame: Within the 12-month follow-up period ]
  Changes of best-corrected visual acuity
• BOS24 score [ Time Frame: Within the 12-month follow-up period ]
  Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)
• Glucocorticoid-sparing effect [ Time Frame: Within the 12-month follow-up period ]
  Changes of corticosteroid dosage
• Incidence of adverse effects [ Time Frame: Within the 12-month follow-up period ]
  Incidence of adverse effects
• Incidence of significant abnormal changes in vital signs or laboratory test results [ Time Frame: Within the 12-month follow-up period ]
  Incidence of significant abnormal changes in vital signs or laboratory test results
• Adverse effects profile [ Time Frame: Within the 12-month follow-up period ]
  Types of drug adverse effects

Original Secondary Outcome Measures (submitted: July 5, 2017)

severity of relapse using the BOS24 [ Time Frame: within the 12-month follow-up period ]

Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
• Official Title: Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Behçet Disease
• Uveitis

Intervention

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

Study Arms

• Experimental: 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.
  Intervention: Drug: Interferon Alfa-2A
• Active Comparator: Cyclosporine
  Patients are treated with oral CsA 100mg twice daily.
  Intervention: Drug: Cyclosporine Pill

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 20, 2021): 28
• Original Estimated Enrollment (submitted: July 5, 2017): 36
• Actual Study Completion Date: January 31, 2021
• Actual Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03209219
• Other Study ID Numbers: Z171100001017217
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: The individual participant data are available from the investigator upon reasonable request.

• Current Responsible Party: Meifen Zhang, Peking Union Medical College Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking Union Medical College Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Peking Union Medical College Hospital
• Verification Date: February 2021