Actively Recruiting
A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2025-04-16
60
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years (inclusive).
- Diagnosed with moderate to severe active thyroid-associated ophthalmopathy based on international criteria.
- Eye disease activity defined by Clinical Activity Score (CAS) of 3 or higher, or CAS of 2 with MRI evidence.
- Normal thyroid function within one month before enrollment, including normal or decreased TSH and normal FT3 and FT4 levels.
- Hamilton Anxiety Rating Scale (HAMA) score of 14 or higher.
- Voluntary participation with informed consent provided.
You will not qualify if you...
- Severe heart, liver, or kidney problems, including recent heart issues or abnormal liver/kidney test results.
- Having a communicable disease.
- Pregnant or planning pregnancy.
- Currently breastfeeding.
- Received radioactive iodine therapy or hepatitis vaccine within three months before enrollment.
- Received systemic immunotherapy for TAO within one month before enrollment.
- Planning other treatments during the study.
- Severe mental disorders affecting study compliance.
- Other significant or unstable systemic diseases.
- Unlikely to complete the full treatment course.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
Y
Yingli Lu
CONTACT
Q
qin li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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