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

Primary Purpose

Uveitis, Adalimumab

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
reduction or discontinuation of Adalimumab
Sponsored by
Dan Liang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring Uveitis, Adalimumab, TNF-α inhibitor

Eligibility Criteria

2 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with inactive uveitis

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best corrected visual Acuity
increase of BCVA
macular structure
Macular thickness (MT). increase of central foveal thickness

Full Information

First Posted
December 9, 2021
Last Updated
December 9, 2021
Sponsor
Dan Liang
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1. Study Identification

Unique Protocol Identification Number
NCT05155592
Brief Title
Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients
Official Title
Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dan Liang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Adalimumab
Keywords
Uveitis, Adalimumab, TNF-α inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with inactive uveitis
Arm Type
Experimental
Arm Description
Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab
Intervention Type
Biological
Intervention Name(s)
reduction or discontinuation of Adalimumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
relapse rate of inflammation
Description
The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Best corrected visual Acuity
Description
increase of BCVA
Time Frame
24 months
Title
macular structure
Description
Macular thickness (MT). increase of central foveal thickness
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Liang, PhD
Phone
0086-20-87330402
Email
liangd2@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Liang, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liang, PhD
Phone
0086-20-87330402
Email
liangd2@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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