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

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155592
• Other study ID #: 2021-ADA-Stop
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: Dan Liang, PhD
• Phone: 0086-20-87330402
• Email: liangd2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adalimumab
• Uveitis

Intervention

Biological:
• reduction or discontinuation of Adalimumab
For patients with non-infectious uveitis whose inflammation stabilizes after treated with Adalimumab, extended dosing intervals to once a month, during which inflammatory status is monitored. If there was no recurrence within 6 months, Adalimumab was discontinued, and whether inflammation recurred after withdrawal was observed.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Dan Liang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse rate of inflammation	The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation	24 months
Secondary	Best corrected visual Acuity	increase of BCVA	24 months
Secondary	macular structure	Macular thickness (MT). increase of central foveal thickness	24 months