Golimumab for the Treatment of Refractory Behcet's Uveitis

NCT04218565 | Terminated Phase 2

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

Brief Summary

The aim of this single-center prospective study is to evaluate the efficacy and safety of Golimumab （GOL）, fully humanized anti-tumor necrosis factor (TNF)-α monoclonal antibody, 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

Outcome Measures

Primary Outcomes (4)

• Efficacy of Golimumab on BD Uveitis

  Efficacy of Golimumab based on Behçet's disease ocular attack score 24 （BOS24）

  four weeks

• Efficacy of Golimumab on BD Uveitis

  Efficacy of Golimumab based on Best corrected visual acuity(BCVA)

  four weeks

• Efficacy of Golimumab on BD Uveitis

  Efficacy of Golimumab based on Optical Coherence tomography(OCT)).

  four weeks

• Difference of recurrence rate before and after intervention

  Difference of recurrence rate of uveitis before and after 12 months of GOL treatment

  12 months

Secondary Outcomes (9)

• Intraocular inflammation evaluation BOS24 index

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

• Corticosteroid-tapering effects

  six months

• Changes of uveitis recurrence

  six months

• Severity of uveitis on recurrence

  six months

• Severity of uveitis on recurrence

  six months

Study Arms (1)

Golimumab for refractory BDU

EXPERIMENTAL

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

Biological: Golimumab (GOL)

Interventions

Golimumab (GOL) BIOLOGICAL

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

Golimumab 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 proposed International Criteria for BD, either ISG (International Study Group) criteria(1990) or ICBD(International Conference on Behcet's Disease) 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, congestive heart failure, or had biologics treatment within three months will be excluded.

Sponsors & Collaborators

• Wenjie Zheng: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Behcet Syndrome; Uveitis

Interventions

golimumab

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: Golimumab is approved for the treatment of several inflammatory diseases, the self-control study aims to evaluate the response to GOL in refractory BDU.

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: January 6, 2020
• Study Start: February 15, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)