Tocilizumab for the Treatment of Refractory Behcet’s Uveitis

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Brief Title

Tocilizumab for the Treatment of Refractory Behcet's Uveitis

Official Title

Efficacy and Safety of Tocilizumab 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
      Tocilizumab (TCZ), humanized monoclonal antibody against IL-6receptor, 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
      treatment strategy of the disease as well as to reduce blindness.

      Tocilizumab (TCZ) is a humanized antibody against IL-6 receptor, clinical trials on
      non-infectious uveitis and retrospective study on BDU has obtained expected results.

      This single-center prospective study is to evaluate the efficacy and safety of TCZ in the
      treatment of refractory BDU, to verify its effects on decreasing the dose of corticosteroids,
      and to determine whether it can reduce BDU recurrence.The investigators aim to enroll nine
      refractory BDU patients with acute onset uveitis, with difficulty tapering corticosteroids
      while being treated with at least one of the commonly used immunosuppressants. All
      participants will receive TCZ , oral corticosteroids and immunosuppressants will remain
      unchanged, intraocular injection will be avoided. During monthly follow-up, the investigators
      will measure and record intraocular inflammation status,as well as extraocular manifestations
      and the acute-phase reactants. The participants will continue to receive TCZ for six months,
      the primary end point is the efficacy four weeks after first dose of TCZ, secondary end
      points other than intraocular inflammation will be achieved on each follow-up visit, as
      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, the study has been reviewed by the PUMCH ethics
      committee, and drug clinical research liability insurance was prepared.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Efficacy of Tocilizumab on BD Uveitis

Secondary Outcome

 Intraocular inflammation evaluation BOS24 index

Condition

Behcet Syndrome

Intervention

Tocilizumab (TCZ)

Study Arms / Comparison Groups

 Tocilizumab 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

May 10, 2018

Completion Date

March 2020

Primary Completion Date

March 2020

Eligibility Criteria

        Inclusion Criteria:

          -  All participants fulfill the the proposed International Criteria for BD, either ISG
             criteria(1990) or ICBD 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 will be excluded.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Wenjie Zheng, M.D., 86-10-69155004, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03554161

Organization ID

TCZ-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

August 2019