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

NCT ID: NCT05155592

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-04-01

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.

Conditions

Uveitis; Adalimumab

Keywords

Uveitis; Adalimumab; TNF-α inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with inactive uveitis

Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab

Group Type: EXPERIMENTAL

reduction or discontinuation of Adalimumab

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dan Liang

OTHER

Sponsor Role: lead

Responsible Party

Dan Liang

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dan Liang, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dan Liang, PhD

Role: CONTACT

Phone: 0086-20-87330402

Email: liangd2@mail.sysu.edu.cn

Facility Contacts

Dan Liang, PhD

Role: primary

References

Yuan PD, Hu YW, Chen XQ, Chen GY, Pan Y, Lao HY, Liang D. Adalimumab Dose Reduction and Withdrawal in Stable Non-Infectious Pediatric Uveitis: An Open-Label, Prospective, Pilot Study. Ocul Immunol Inflamm. 2025 Apr;33(3):332-339. doi: 10.1080/09273948.2024.2343084. Epub 2024 Apr 23.

Reference Type: DERIVED

PMID: 38652891 (View on PubMed)

Teabagy S, Wood E, Bilsbury E, Doherty S, Janardhana P, Lee DJ. Ocular immunosuppressive microenvironment and novel drug delivery for control of uveitis. Adv Drug Deliv Rev. 2023 Jul;198:114869. doi: 10.1016/j.addr.2023.114869. Epub 2023 May 10.

Reference Type: DERIVED

PMID: 37172782 (View on PubMed)

Other Identifiers

2021-ADA-Stop

Identifier Type: -

Identifier Source: org_study_id