Tocilizumab for the Treatment of Refractory Behcet's Uveitis
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|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
|Condition or disease||Intervention/treatment||Phase|
|Behcet Syndrome Uveitis||Biological: Tocilizumab (TCZ)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||3 participants|
|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)|
|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|
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.
- Efficacy of Tocilizumab on BD Uveitis [ Time Frame: four weeks ]Remission or deterioration of uveitis，based on intraocular inflammation evaluation
- 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.
- Corticosteroid-tapering effects [ Time Frame: six months ]Whether corticosteroid dosage could be tapered to minimum dose.
- 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
- 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
- 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
- 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
- Side effects of treatment [ Time Frame: each follow-up visit / every four weeks, up to six months ]Record any side effects during intervention
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
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100730|
|Principal Investigator:||Wenjie Zheng, M.D.||Department of Rheumatology, Peking Union Medical College Hospital|