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New treatment option for Thyroid-Associated Ophthalmopathy
Official title A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy
ClinicalTrials.gov ID: NCT06927375
What this study is testing
What is Tocilizumab(400mg) combined with Flupentixol Melitracen(0.5mg:10mg)?
Tocilizumab(400mg) combined with Flupentixol Melitracen(0.5mg:10mg) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for thyroid-associated ophthalmopathy.
Also referred to as study group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- Normal thyroid function within one month prior to enrollment: including those currently taking antithyroid drugs or not requiring medication, with...
- HAMA (Hamilton Anxiety Rating Scale) score of ≥14.
- Voluntary participation and provision of informed consent.
You likely can't join if
- Severe cardiac, hepatic, or renal insufficiency (including myocardial ischemia or myocardial infarction, arrhythmias, and heart failure; ALT, AST ≥ 3...
- 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...
See the full eligibility 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...
- 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...
- HAMA (Hamilton Anxiety Rating Scale) score of ≥14.
- Voluntary participation and provision of informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.