Uveitis Clinical Trial
Official title:
Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease
Verified date | April 2023 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Wenjie Zheng |
China,
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 |
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