Clinical trial

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

Name

GOL-BDU-PUMCH

Description

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.

Trial arms

Trial start

2020-02-15

Estimated PCD

2022-12-15

Trial end

2022-12-15

Status

Terminated

Phase

Early phase I

Treatment

Golimumab (GOL)

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

Arms:

Golimumab for refractory BDU

Size

Primary endpoint

Efficacy of Golimumab on BD Uveitis

four weeks

Efficacy of Golimumab on BD Uveitis

four weeks

Efficacy of Golimumab on BD Uveitis

four weeks

Difference of recurrence rate before and after intervention

12 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Golimumab is approved for the treatment of several inflammatory diseases, the self-control study aims to evaluate the response to GOL in refractory BDU.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

Updated at

2023-04-07

1 organization

1 product

2 indications

Organization

Product

Indication

Indication