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Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

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

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.

Condition or disease Intervention/treatment Phase
Behçet Disease Uveitis Drug: Interferon Alfa-2A Drug: Cyclosporine Pill Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : January 31, 2021


Arm Intervention/treatment
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.
Drug: Interferon Alfa-2A
3×10^6 IU, subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter

Active Comparator: Cyclosporine
Patients are treated with oral CsA 100mg twice daily.
Drug: Cyclosporine Pill
100mg, oral, bid




Primary Outcome Measures :
  1. Response rate [ Time Frame: Within the 12-month follow-up period ]
    Percentage of participants who achieve complete remission or partial remission

  2. 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

  3. Tolerance rate [ Time Frame: Within the 12-month follow-up period ]
    Percentage of participants who adhere to the treatment without severe side effects


Secondary Outcome Measures :
  1. 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

  2. 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

  3. BCVA [ Time Frame: Within the 12-month follow-up period ]
    Changes of best-corrected visual acuity

  4. BOS24 score [ Time Frame: Within the 12-month follow-up period ]
    Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)

  5. Glucocorticoid-sparing effect [ Time Frame: Within the 12-month follow-up period ]
    Changes of corticosteroid dosage

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

  7. 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

  8. Adverse effects profile [ Time Frame: Within the 12-month follow-up period ]
    Types of drug adverse effects



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209219


Locations
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China, Beijing
Peking Union Medical College
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
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Responsible Party: Meifen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03209219    
Other Study ID Numbers: Z171100001017217
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data are available from the investigator upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meifen Zhang, Peking Union Medical College Hospital:
effectiveness, safety
Additional relevant MeSH terms:
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Behcet Syndrome
Uveitis
Uveal Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Interferons
Interferon-alpha
Interferon alpha-2
Cyclosporine
Cyclosporins
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents