NCT06927375 A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy
| NCT ID | NCT06927375 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Condition | Thyroid-Associated Ophthalmopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2025-11-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-12-12 with a primary completion date of 2025-11-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility 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.
Contact & Investigator
Yingli Lu
STUDY CHAIR
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China
Frequently Asked Questions
Who can join the NCT06927375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Thyroid-Associated Ophthalmopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06927375 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06927375 currently recruiting?
Yes, NCT06927375 is actively recruiting participants. Contact the research team at luyingli2008@126.com for enrollment information.
Where is the NCT06927375 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06927375 clinical trial?
NCT06927375 is sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. The principal investigator is Yingli Lu at Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China. The trial plans to enroll 60 participants.