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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03554161
Other study ID # TCZ-BDU-PUMCH
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 10, 2018
Est. completion date February 1, 2021

Study information

Verified date March 2021
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Tocilizumab (TCZ)
Patients with refractory BD associated uveitis will receive Tocilizumab therapy, the efficacy and corticosteroids-tapering effects will be evaluated.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Wenjie Zheng

Country where clinical trial is conducted

China, 

References & Publications (2)

Atienza-Mateo B, Calvo-Río V, Beltrán E, Martínez-Costa L, Valls-Pascual E, Hernández-Garfella M, Atanes A, Cordero-Coma M, Miquel Nolla J, Carrasco-Cubero C, Loricera J, González-Vela MC, Vegas-Revenga N, Fernández-Díaz C, Demetrio-Pablo R, Domínguez-Cas — View Citation

Lopalco G, Fabiani C, Sota J, Lucherini OM, Tosi GM, Frediani B, Iannone F, Galeazzi M, Franceschini R, Rigante D, Cantarini L. IL-6 blockade in the management of non-infectious uveitis. Clin Rheumatol. 2017 Jul;36(7):1459-1469. doi: 10.1007/s10067-017-36 — View Citation

Outcome

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