TerminatedPhase 2

Golimumab for the Treatment of Refractory Behcet's Uveitis

Stopped: only one patient enrolled

China1 participantsStarted 2020-02-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

Efficacy of Golimumab on BD Uveitis

Timeframe: four weeks

Efficacy of Golimumab on BD Uveitis

Timeframe: four weeks

Efficacy of Golimumab on BD Uveitis

Timeframe: four weeks

Difference of recurrence rate before and after intervention

Timeframe: 12 months

Trial details

NCT IDNCT04218565

SponsorWenjie Zheng

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-15

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