Clinical trial NCT06087731: Efficacy and Safety of Tocilizumab for TAO
Official title: Efficacy and Safety of Tocilizumab for Patients With Thyroid-associated Ophthalmopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Tocilizumab
Thyroid Associated Ophthalmopathy
Keywords: Thyroid Associated Ophthalmopathy
tocilizumab
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of tocilizumab treating Thyroid Associated Ophthalmopathy.

Detailed description: Thyroid Associated Ophthalmopathy(TAO) is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. In TAO pathogenesis, orbital fibroblasts are activated by autoantibodies against the thyrotropin receptor TSHR and the insulin-like growth factor-1 receptor. The fibroblasts then secrete interleukin-6 (IL-6), macrophage chemoattractant protein-1, and transforming growth factor-ß. In orbital preadipocyte fibroblasts, IL-6 increases expression of the thyrotropin receptor TSHR, and the orbital volume is relative to IL-6 mRNA expression. Thus, IL-6 may have several roles in the pathogenesis of TAO. Tocilizumab, a recombinant humanized IgG1 monoclonal antibody against IL-6 receptors, is FDA-approved for the treatment of rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis with a good toleration. The investigators carry this perspective cohort study to evaluate the efficacy of tocilizumab in TAO.

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

Primary outcomes:
measure: volume and signal intensity of each extraocular muscles and soft tissue in MRI images
timeFrame: month 1，month 3，month 6
measure: Clinical Activity Score
timeFrame: month 1，month 3，month 6
measure: eyelid aperture
timeFrame: month 1，month 3，month 6
measure: exophthalmos
timeFrame: month 1，month 3，month 6
measure: eyelid lag
timeFrame: month 1，month 3，month 6
measure: retraction of the upper and lower eyelids
timeFrame: month 1，month 3，month 6
Secondary outcomes:
measure: ocular motility
timeFrame: month 1，month 3，month 6
measure: Graves' Ophthalmopathy Quality of Life Scale
timeFrame: month 1，month 3，month 6
measure: inflammatory markers changes
timeFrame: month 1，month 3，month 6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Dan Liang
role: PRINCIPAL_INVESTIGATOR
References: