Behcet Syndrome, Uveitis
Conditions
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.
Detailed 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.
Interventions
BIOLOGICALGolimumab (GOL)
Patients with refractory BD associated uveitis will receive Golimumab therapy, the efficacy and corticosteroids-sparing effects will be evaluated.
Sponsors
Wenjie Zheng
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Golimumab is approved for the treatment of several inflammatory diseases, the self-control study aims to evaluate the response to GOL in refractory BDU.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Golimumab on BD Uveitis | four weeks | Efficacy of Golimumab based on Behçet's disease ocular attack score 24 （BOS24） |
| Difference of recurrence rate before and after intervention | 12 months | Difference of recurrence rate of uveitis before and after 12 months of GOL treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of uveitis recurrence | six months | Changes of recurrence rate before and after six months of GOL treatment. |
| Severity of uveitis on recurrence | six months | Differences of severity of recurrence before and after treatment, measured by BOS24. |
| Intraocular inflammation evaluation BOS24 index | each follow-up visit / every four weeks, up to six months | Visual acuity, anterior chamber cells, vitreous opacities, retinal inflammation, macular thickness, etc. |
| Side effects of treatment | six months | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Impact on quality of life | each follow-up visit / every four weeks, up to six months | Record quality of life on questionnaire, BehÇet's disease current activity form 2006（BDCAF2006）. |
| Corticosteroid-tapering effects | six months | Corticosteroid will be tapered to minimum dose(Prednisone 5-10mg/d) within four months during the course of GOL treatment. |
Countries
China
Outcome results
None listed