Golimumab for the Treatment of Refractory Behcet’s Uveitis

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Brief Title

Golimumab for the Treatment of Refractory Behcet's Uveitis

Official Title

Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease

Brief Summary

      The aim of this single-center prospective study is to evaluate the efficacy and safety of
      Golimumab (GOL), fully humanized anti-tumor necrosis factor (TNF)-α monoclonal antibody, in
      the treatment of refractory Uveitis of Behçet's disease (BDU), to verify its effects on
      decreasing the dose of cortical steroids, and to determine whether it can reduce BDU
      recurrence.
    

Detailed Description

      Uveitis of Behçet's disease (BDU) is the most common form of ocular manifestations, which is
      also the leading cause of irreversible visual impairment. The aim of the study is to improve
      the treatment strategy of the disease as well as to reduce blindness.

      Monoclonal anti-TNF antibodies were recommended in 2018 recommendations for treating eye
      involvement affecting the posterior segment (level of evidence: IIA; strength of
      recommendation: B), Infliximab was mentioned for the treatment of initial or recurrent
      episode of acute sight-threatening uveitis.

      Golimumab (GOL)is a fully-humanized anti-TNF-α monoclonal antibody, retrospective study on
      non-infectious uveitis and BDU has obtained promising results.

      This single-center prospective study is to evaluate the efficacy and safety of GOL in the
      treatment of refractory BDU, to verify its effects on tapering the dose of corticosteroids,
      and to determine whether it can reduce BDU recurrence. We aim to enroll nine refractory BDU
      patients with acute onset posterior uveitis, with difficulty tapering corticosteroids while
      being treated with at least one of the commonly used immunosuppressants.

      All participants will receive GOL monthly for six months, oral immunosuppressants will remain
      unchanged. During follow-up, intraocular inflammation status, BCVA, as well as extraocular
      manifestations, will be recorded. The primary endpoints are the efficacy of the first dose of
      GOL, and the recurrence of uveitis after 12 months of treatment. Secondary endpoints other
      than intraocular inflammation will be achieved on each follow-up visit, as the quality of
      life improvements, side effects, recurrence of uveitis, and corticosteroids-tapering effects.

      On statistical analysis, the self-control treatment efficiency and recurrence rate difference
      will be determined using T-test of paired samples at a significance level of 0.05(2-sided).

      To ensure the interest of the participants, our study has been reviewed by the ethics
      committee, and drug clinical research liability insurance was prepared.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Efficacy of Golimumab on BD Uveitis

Secondary Outcome

 Intraocular inflammation evaluation BOS24 index

Condition

Behcet Syndrome

Intervention

Golimumab (GOL)

Study Arms / Comparison Groups

 Golimumab for refractory BDU
Description:  This study is a self-control study and all the participants will be enrolled in the interventional arm.

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

Biological

Estimated Enrollment

9

Start Date

February 15, 2020

Completion Date

December 15, 2022

Primary Completion Date

December 15, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  All participants fulfill the proposed International Criteria for BD, either ISG
             (International Study Group) criteria(1990) or ICBD(International Conference on
             Behcet's Disease) criteria(2013).

          -  All participants present with refractory BDU, acute onset uveitis, either posterior
             segment involvement or panuveitis, with difficulty tapering corticosteroids while
             being treated with at least one of the commonly used immunosuppressants, without
             severe extraocular manifestations.

        Exclusion Criteria:

          -  Patients with impaired hepatic and renal function, other severe ocular diseases,
             active tuberculosis, viral hepatitis, malignancy, pregnancy, congestive heart failure,
             or had biologics treatment within three months will be excluded.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Wenjie Zheng, M.D., +8613581605769, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04218565

Organization ID

GOL-BDU-PUMCH


Responsible Party

Sponsor-Investigator

Study Sponsor

Wenjie Zheng


Study Sponsor

Wenjie Zheng, M.D., Principal Investigator, Department of Rheumatology, Peking Union Medical College Hospital


Verification Date

March 2020