Interferon α2a Versus Cyclosporine for Refractory Behçet`s Disease Uveitis

Learn more about:
Related Clinical Trial
Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis Cyclosporine A in the Treatment of Juvenile Idiopathic Arthritis (JIA) Associated Chronic Anterior Uveitis Screening for NEI Clinical Studies Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications HAT in Eye Complications of Behcet’s Disease Golimumab for the Treatment of Refractory Behcet’s Uveitis Tocilizumab for the Treatment of Refractory Behcet’s Uveitis Prevalence of Toxoplasma Gondii and Toxocara Canis Among Patients With Uveitis Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis Interferon α2a Versus Cyclosporine for Refractory Behçet`s Disease Uveitis A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis Adalimumab vs. Conventional Immunosuppression for Uveitis Trial Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB) Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis Quality of Life and Visual Function in Uveitis Patients Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

relapse rate

Secondary Outcome

 severity of relapse using the BOS24

Condition

Behçet Disease

Intervention

Interferon Alfa-2A

Study Arms / Comparison Groups

 Interferon Alpha 2A
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

June 30, 2017

Completion Date

January 2021

Primary Completion Date

January 2020

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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, +86-10-69156351, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03209219

Organization ID

Z171100001017217


Responsible Party

Principal Investigator

Study Sponsor

Peking Union Medical College Hospital


Study Sponsor

, , 


Verification Date

June 2018