A Phase 2 interventional study of Golimumab (GOL) in Behcet Syndrome and Uveitis, sponsored by Wenjie Zheng. Terminated at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Wenjie Zheng · Phase 2, Interventional, and Treatment
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.
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.
136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.
This study's enrollment of 1 is below the median of 50 across 70 interventional studies indexed under Behcet Syndrome.
Browse Behcet Syndrome studies →Wenjie Zheng is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
This study is a self-control study and all the participants will be enrolled in the interventional arm.
Biological: Golimumab (GOL)
Patients with refractory BD associated uveitis will receive Golimumab therapy, the efficacy and corticosteroids-sparing effects will be evaluated.
Efficacy of Golimumab on BD Uveitis
Efficacy of Golimumab based on Behçet's disease ocular attack score 24 （BOS24）
Time frame: four weeks
Efficacy of Golimumab on BD Uveitis
Efficacy of Golimumab based on Best corrected visual acuity(BCVA)
Time frame: four weeks
Efficacy of Golimumab on BD Uveitis
Efficacy of Golimumab based on Optical Coherence tomography(OCT)).
Time frame: four weeks
Difference of recurrence rate before and after intervention
Difference of recurrence rate of uveitis before and after 12 months of GOL treatment
Time frame: 12 months
Intraocular inflammation evaluation BOS24 index
Visual acuity, anterior chamber cells, vitreous opacities, retinal inflammation, macular thickness, etc.
Time frame: each follow-up visit / every four weeks, up to six months
Corticosteroid-tapering effects
Corticosteroid will be tapered to minimum dose(Prednisone 5-10mg/d) within four months during the course of GOL treatment.
Time frame: six months
Changes of uveitis recurrence
Changes of recurrence rate before and after six months of GOL treatment.
Time frame: six months
Severity of uveitis on recurrence
Differences of severity of recurrence before and after treatment, measured by BOS24.
Time frame: six months
Severity of uveitis on recurrence
Differences of severity of recurrence before and after treatment, measured by , BCVA.
Time frame: six months
Severity of uveitis on recurrence
Differences of severity of recurrence before and after treatment, measured by OCT.
Time frame: six months
Impact on quality of life
Record quality of life on questionnaire, BehÇet's disease current activity form 2006（BDCAF2006）.
Time frame: each follow-up visit / every four weeks, up to six months
Impact on quality of life
Record quality of life on questionnaire, short from Health Survey(SF-36).
Time frame: each follow-up visit / every four weeks, up to six months
Side effects of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: six months
Plan to share: No
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This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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