Golimumab for the Treatment of Refractory Behcet's Uveitis

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04218565
• Other study ID #: GOL-BDU-PUMCH
• Status: Terminated
• Phase: Phase 2
• Start date: February 15, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: April 2023
• 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 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.

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 the treatment strategy of the disease as well as to reduce blindness.

Monoclonal anti-TNF antibodies were recommended in 2018 recommendations for treating eye involvement affecting the posterior segment (level of evidence: IIA; strength of recommendation: B), Infliximab was mentioned for the treatment of initial or recurrent episode of acute sight-threatening uveitis.

Golimumab （GOL）is a fully-humanized anti-TNF-α monoclonal antibody, retrospective study on non-infectious uveitis and BDU has obtained promising results.

This single-center prospective study is to evaluate the efficacy and safety of GOL in the treatment of refractory BDU, to verify its effects on tapering the dose of corticosteroids, and to determine whether it can reduce BDU recurrence. We aim to enroll nine refractory BDU patients with acute onset posterior uveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants.

All participants will receive GOL monthly for six months, oral immunosuppressants will remain unchanged. During follow-up, intraocular inflammation status, BCVA, as well as extraocular manifestations, will be recorded. The primary endpoints are the efficacy of the first dose of GOL, and the recurrence of uveitis after 12 months of treatment. Secondary endpoints other than intraocular inflammation will be achieved on each follow-up visit, as the 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, our study has been reviewed by the ethics committee, and drug clinical research liability insurance was prepared.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Behcet Syndrome
• Uveitis

Intervention

Biological:
• Golimumab (GOL)
Patients with refractory BD associated uveitis will receive Golimumab therapy, the efficacy and corticosteroids-sparing 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Golimumab on BD Uveitis	Efficacy of Golimumab based on Behçet's disease ocular attack score 24 (BOS24)	four weeks
Primary	Efficacy of Golimumab on BD Uveitis	Efficacy of Golimumab based on Best corrected visual acuity(BCVA)	four weeks
Primary	Efficacy of Golimumab on BD Uveitis	Efficacy of Golimumab based on Optical Coherence tomography(OCT)).	four weeks
Primary	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	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	Corticosteroid will be tapered to minimum dose(Prednisone 5-10mg/d) within four months during the course of GOL treatment.	six months
Secondary	Changes of uveitis recurrence	Changes of recurrence rate before and after six months of GOL treatment.	six months
Secondary	Severity of uveitis on recurrence	Differences of severity of recurrence before and after treatment, measured by BOS24.	six months
Secondary	Severity of uveitis on recurrence	Differences of severity of recurrence before and after treatment, measured by , BCVA.	six months
Secondary	Severity of uveitis on recurrence	Differences of severity of recurrence before and after treatment, measured by OCT.	six months
Secondary	Impact on quality of life	Record quality of life on questionnaire, BehÇet's disease current activity form 2006(BDCAF2006).	each follow-up visit / every four weeks, up to six months
Secondary	Impact on quality of life	Record quality of life on questionnaire, short from Health Survey(SF-36).	each follow-up visit / every four weeks, up to six months
Secondary	Side effects of treatment	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	six months