Clinical Trial

A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy

Recruiting Phase 4
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Record status
This record was last updated April 16, 2025 (before its estimated November 12, 2025 completion). Its status may not reflect the trial's current state.
Summary
Thyroid-associated ophthalmopathy (TAO) is a serious, progressive, vision-threatening autoimmune disease that can be categorized into mild, moderate, and severe stages based on severity. The activity of TAO is commonly evaluated using the Clinical Activity Score (CAS). Tocilizumab serves as a second-line treatment option for patients with moderate to severe active TAO. Additionally, it is common for TAO patients to experience anxiety, which may exacerbate their condition and negatively impact prognosis. Therefore, we have designed this randomized controlled study to evaluate the impact of Flupentixol Melitracen (Lepan) on the treatment outcomes of participants receiving Tocilizumab (Actemra).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-07.
Trial Details
NCT Number NCT06927375
Lead Sponsor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions Thyroid-Associated Ophthalmopathy
Enrollment 60 participants
Start Date 2024-12-12
Primary Completion 2025-11-12 (estimated)
Study Completion 2026-03-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-16