Tocilizumab for the Treatment of Refractory Behcet's Uveitis

NCT03554161 | Terminated Phase 2

• 1 other identifier: TCZ-BDU-PUMCH
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet Syndrome; Uveitis

Keywords

Tocilizumab; Refractory uveitis

Outcome Measures

Primary Outcomes (1)

• Efficacy of Tocilizumab on BD Uveitis

  Remission or deterioration of uveitis，based on intraocular inflammation evaluation

  four weeks

Secondary Outcomes (7)

• Intraocular inflammation evaluation BOS24 index

  each follow-up visit / every four weeks, up to six months

• Corticosteroid-tapering effects

  six months

• Reduction of uveitis recurrence

  each follow-up visit / every four weeks, up to six months

• Severity of uveitis on recurrence

  each follow-up visit / every four weeks, up to six months

• Improvement of quality of life

  each follow-up visit / every four weeks, up to six months

Study Arms (1)

Tocilizumab for refractory BDU

EXPERIMENTAL

This study is a self-control study and all the participants will be enrolled in the interventional arm.

Biological: Tocilizumab (TCZ)

Interventions

Tocilizumab (TCZ) BIOLOGICAL

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

Tocilizumab for refractory BDU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with impaired hepatic and renal function, other severe ocular diseases, active tuberculosis, viral hepatitis, malignancy, pregnancy will be excluded.

Sponsors & Collaborators

• Wenjie Zheng: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• Atienza-Mateo B, Calvo-Rio V, Beltran E, Martinez-Costa L, Valls-Pascual E, Hernandez-Garfella M, Atanes A, Cordero-Coma M, Miquel Nolla J, Carrasco-Cubero C, Loricera J, Gonzalez-Vela MC, Vegas-Revenga N, Fernandez-Diaz C, Demetrio-Pablo R, Dominguez-Casas LC, Luis Martin-Varillas J, Palmou-Fontana N, Hernandez JL, Gonzalez-Gay MA, Blanco R. Anti-interleukin 6 receptor tocilizumab in refractory uveitis associated with Behcet's disease: multicentre retrospective study. Rheumatology (Oxford). 2018 May 1;57(5):856-864. doi: 10.1093/rheumatology/kex480.

  PMID: 29471416 RESULT

• 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/s10067-017-3672-z. Epub 2017 May 20.

  PMID: 28528519 RESULT

Related Links

• Springerlink

MeSH Terms

Conditions

Behcet Syndrome; Uveitis

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Wenjie Zheng, M.D.

  Department of Rheumatology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor， Department of Rheumatology

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: June 13, 2018
• Study Start: May 10, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

CN (1)