Status:
RECRUITING
A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Thyroid-Associated Ophthalmopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Thyroid-associated ophthalmopathy (TAO) is a serious, progressive, vision-threatening autoimmune disease with an incidence rate of about 19-42 per 100,000. Currently, it ranks first among orbital dise...
Eligibility Criteria
Inclusion
- Aged between 18 and 80 years (inclusive).
- Meets internationally recognized diagnostic criteria for TED with the more severely affected eye in moderate to severe active phase. Meeting any one of the following criteria qualifies as moderate to severe: an exophthalmos ≥2 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm. A Clinical Activity Score (CAS) of ≥3 or a score of 2 combined with MRI evidence indicating active disease is defined as active.
- Normal thyroid function within one month prior to enrollment: including those currently taking antithyroid drugs or not requiring medication, with FT3 and FT4 levels within normal range and TSH either normal or decreased.
- HAMA (Hamilton Anxiety Rating Scale) score of ≥14.
- Voluntary participation and provision of informed consent.
Exclusion
- Severe cardiac, hepatic, or renal insufficiency (including myocardial ischemia or myocardial infarction, arrhythmias, and heart failure; ALT, AST ≥ 3 times the upper limit of normal; eGFR \< 60 ml/min/1.73 m²).
- communicable disease.
- Pregnancy or planning to become pregnant.
- Currently breastfeeding.
- Received radioactive iodine treatment or hepatitis vaccination within three months prior to enrollment.
- Received systemic immunotherapy for TAO, including oral or intravenous glucocorticoids, other immunosuppressants, or orbital radiotherapy within one month prior to enrollment.
- Planning to undergo other treatments during the course of this study.
- Severe mental disorders that affect compliance.
- Presence of other clinically significant or unstable systemic diseases.
- Patients who are unlikely to complete the entire course of treatment.
Key Trial Info
Start Date :
December 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 12 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06927375
Start Date
December 12 2024
End Date
March 12 2026
Last Update
April 16 2025
Active Locations (1)
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1
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011