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Tocilizumab for the Treatment of Refractory Behcet's Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554161
Recruitment Status : Terminated (The study was terminated based on its primary and secondary outcome measures in three consecutive patients.)
First Posted : June 13, 2018
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Wenjie Zheng, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Behcet Syndrome Uveitis Biological: Tocilizumab (TCZ) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Tocilizumab is approved for the treatment of several inflammatory disease, this study tends to evaluate the response to TCZ in refractory BDU, thus it is a self-control study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tocilizumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease
Actual Study Start Date : May 10, 2018
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of Tocilizumab on BD Uveitis [ Time Frame: four weeks ]
    Remission or deterioration of uveitis，based on intraocular inflammation evaluation


Secondary Outcome Measures :
  1. 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.

  2. Corticosteroid-tapering effects [ Time Frame: six months ]
    Whether corticosteroid dosage could be tapered to minimum dose.

  3. 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

  4. 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

  5. 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

  6. 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

  7. Side effects of treatment [ Time Frame: each follow-up visit / every four weeks, up to six months ]
    Record any side effects during intervention


Eligibility Criteria
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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:

  • 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.
Contacts and Locations
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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): NCT03554161


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Wenjie Zheng
Investigators
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Principal Investigator: Wenjie Zheng, M.D. Department of Rheumatology, Peking Union Medical College Hospital
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Wenjie Zheng, Professor， Department of Rheumatology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03554161    
Other Study ID Numbers: TCZ-BDU-PUMCH
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Wenjie Zheng, Peking Union Medical College Hospital:
Tocilizumab
Refractory uveitis
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