Combining Tocilizumab and Flupentixol-Melitracen for Thyroid Eye Disease Treatment
Clinical Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy: A Prospective Exploratory Study
This study is testing if combining two medications, Tocilizumab and Flupentixol-Melitracen, can help people with thyroid eye disease feel better and improve their eye symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Drugs / interventions | immunotherapy, Tocilizumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06927375 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with moderate to severe active thyroid-associated ophthalmopathy and elevated anxiety levels.
Not a fit: Patients with severe cardiac, hepatic, or renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with thyroid-associated ophthalmopathy.
How similar studies have performed: While Tocilizumab has been used in similar contexts, the combination with Flupentixol Melitracen is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.