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

StatusRecruiting
PhasePhase 4
Started
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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.

Record History

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  1. Eligibility criteria revisedv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06927375
Lead Sponsor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions
(from sponsor)		 Thyroid-Associated Ophthalmopathy
Related terms Graves Ophthalmopathy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov