Tocilizumab for the Treatment of Refractory Behcet's Uveitis

March 17, 2021 updated by: Wenjie Zheng

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tocilizumab for refractory BDU
This study is a self-control study and all the participants will be enrolled in the interventional arm.
Biological: Tocilizumab (TCZ)
Patients with refractory BD associated uveitis will receive Tocilizumab therapy, the efficacy and corticosteroids-tapering effects will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Tocilizumab on BD Uveitis
Time Frame: four weeks
Remission or deterioration of uveitis，based on intraocular inflammation evaluation
four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular inflammation evaluation BOS24 index
Time Frame: each follow-up visit / every four weeks, up to six months
Visual acuity, anterior chamber cells, vitreous opacities, retinal inflammation, macular thickness, etc.
each follow-up visit / every four weeks, up to six months
Corticosteroid-tapering effects
Time Frame: six months
Whether corticosteroid dosage could be tapered to minimum dose.
six months
Reduction of uveitis recurrence
Time Frame: each follow-up visit / every four weeks, up to six months
Differences of recurrence between before and after treatment
each follow-up visit / every four weeks, up to six months
Severity of uveitis on recurrence
Time Frame: each follow-up visit / every four weeks, up to six months
Differences of severity of recurrence between before and after treatment
each follow-up visit / every four weeks, up to six months
Improvement of quality of life
Time Frame: each follow-up visit / every four weeks, up to six months
Record quality of life on questionnaire: BDCAF
each follow-up visit / every four weeks, up to six months
Improvement of quality of life
Time Frame: each follow-up visit / every four weeks, up to six months
Record quality of life on questionnaire: SF-36
each follow-up visit / every four weeks, up to six months
Side effects of treatment
Time Frame: each follow-up visit / every four weeks, up to six months
Record any side effects during intervention
each follow-up visit / every four weeks, up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenjie Zheng

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2018

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

April 21, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCZ-BDU-PUMCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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