Golimumab in refractory non-infectious ocular inflammatory disease in Siriraj hospital

Not Applicable

Completed

• Conditions: refractory ocular inflammationVKHbehcet' s diseaseidiopathic panuveitispsoriasis anterior uveitisscleritisnonrandomized retrospective case series; TNF- alpha; golimumab; non infectious ocular Inflammatory disease; Refractory ocular inflammation; VKH; Behcet' s disease

• Registration Number: TCTR20200515002
• Lead Sponsor: Faculty of Medicine Siriraj Hospital Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-08-30
• Study Start: 2020-05-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1) non-infectious eye inflammation which could not be controlled with prednisolone ≥ 10 mg/day combined with 2 immunosuppressive agents (refractory to treatment) or having adverse effects which required IMS cessation
2) patients agree to use GLM treatment (50 mg subcutaneous injection every 4 weeks) and are able to follow the treatment schedule

Exclusion Criteria

1) patients affected with or suspected of infectious ocular inflammation
2) patients with active or history of tuberculosis
3) known allergy history of golimumab or related products
4) pregnant subjects

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
steroid dosage and number IMS agent before use golimumab 1 month, at every dose of golimumab until Aug 2019 dosage and number of agent,response to golimumab before use golimumab 1 month, at every dose of golimumab until Aug 2019 frequency of active inflammatory episodes before and after GLM treatment

Secondary Outcome Measures

Name	Time	Method
safety before use golimumab 1 month, at every dose of golimumab until Aug 2019 developed adverse events after GLM treatment