NCT05155592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

December 9, 2021

Last Update Submit

December 9, 2021

Conditions

UveitisAdalimumab

Keywords

UveitisAdalimumabTNF-α inhibitor

Outcome Measures

Primary Outcomes (1)

  • relapse rate of inflammation

    The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation

    24 months

Secondary Outcomes (2)

  • Best corrected visual Acuity

    24 months

  • macular structure

    24 months

Study Arms (1)

Patients with inactive uveitis

EXPERIMENTAL

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

Biological: reduction or discontinuation of Adalimumab

Interventions

reduction or discontinuation of AdalimumabBIOLOGICAL

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.

Patients with inactive uveitis

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38652891DERIVED

  • 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.

    PMID: 37172782DERIVED

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Dan Liang, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Liang, PhD

CONTACT

0086-20-87330402liangd2@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 13, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

December 13, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)