Combining Tocilizumab and Flupentixol-Melitracen for Thyroid Eye Disease Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of combining Tocilizumab, a second-line treatment for moderate to severe thyroid-associated ophthalmopathy (TAO), with Flupentixol Melitracen, a medication that may help alleviate anxiety in patients. The study aims to determine if this combination improves treatment outcomes for patients suffering from this vision-threatening autoimmune disease. Participants will be monitored for changes in their Clinical Activity Score (CAS) and overall ocular symptoms. The trial is randomized and controlled, ensuring a rigorous assessment of the intervention's efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Qin Li — Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China
• Study coordinator: Yingli Lu
• Email: luyingli2008@126.com
• Phone: （021）+86 13636352507

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.