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Clinical trial

Efficacy and Safety of Tocilizumab for Patients With Thyroid-associated Ophthalmopathy

ID
Name
2023TAOIL-6
Description
This study aims to evaluate the efficacy and safety of tocilizumab treating Thyroid Associated Ophthalmopathy.
Trial arms
Trial start
2023-09-23
Estimated PCD
2023-09-23
Trial end
2023-09-23
Status
Withdrawn
Phase
Early phase I
Treatment
Tocilizumab
Tocilizumab (8mg/kg) every 4 wekks
Arms:
tocilizumab
Primary endpoint
volume and signal intensity of each extraocular muscles and soft tissue in MRI images
month 1，month 3，month 6
Clinical Activity Score
month 1，month 3，month 6
eyelid aperture
month 1，month 3，month 6
exophthalmos
month 1，month 3，month 6
eyelid lag
month 1，month 3，month 6
retraction of the upper and lower eyelids
month 1，month 3，month 6
Eligibility criteria
Inclusion criteria: Age 18-70 years old * Clinical diagnosis of Thyroid-associated ophthalmopathy * Euthyroid status at least 1 months before baseline. * No previous specific therapy for TAO, except for local measures * Written informed consent is obtained Exclusion criteria: * Uncontrolled diabetes or hypertension * Renal or hepatic insufficiency. * Infectious diseases (HIV, HBV,TB and so on) * History of mental/psychiatric disorder * Other ocular diseases or fundus diseases. * Any previous systemic medications or surgery for the treatment of TAO * Pregnant or lactating females. * Intolerability of tocilizumab
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-11-28

1 organization

1 drug

2 indications

Organization
Sun Yat-sen University
Drug
Tocilizumab
Indication
Tocilizumab
Indication
Graves' Disease