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

Recruiting now · Phase 4

Conditions studied: Thyroid-Associated Ophthalmopathy

In brief

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).

Key facts

Study ID

NCT06927375

Run by

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

People needed

60

Starts

2024-12-12

Expected to finish

2026-03-12

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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