Tocilizumab for the Treatment of Refractory Behcet's Uveitis

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03554161
• Other study ID #: TCZ-BDU-PUMCH
• Status: Terminated
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Behcet Syndrome
• Uveitis

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

External Links

•   Oxford Academic Rheumatology
•   Springerlink