NCT05155592

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Dan Liang · Academic / Other
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2021-12-13
• Last updated: 2021-12-13

Locations

1 site across 1 country: China