Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients

Phase 2

• Conditions: Uveitis; Adalimumab
• Interventions: Biological: reduction or discontinuation of Adalimumab

• Registration Number: NCT05155592
• Lead Sponsor: Dan Liang

Brief Summary

TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Detailed Description

TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Last Update Submitted: 2021-12-09
• Study First Posted: 2021-12-13
• Last Update Posted: 2021-12-13
• Primary Completion: 2023-01-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Clinical diagnosis of non-infectious uveitis
• nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy
• Family members and patients who are willing to stop should agree and accept relevant examinations
• The informed consent is read and signed by the patient or a legally authorized represent

Exclusion Criteria

• Unwilling to sign informed consent
• There is systemic autoimmune disease uncontrolled situation
• Patients who may require surgery in the near future
• Vision meets the standards of low vision and blindness
• Silicone oil or gas filling after vitreous surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with inactive uveitis	reduction or discontinuation of Adalimumab	Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab

Primary Outcome Measures

Name	Time	Method
relapse rate of inflammation	24 months	The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation

Secondary Outcome Measures

Name	Time	Method
macular structure	24 months	Macular thickness (MT). increase of central foveal thickness
Best corrected visual Acuity	24 months	increase of BCVA

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China