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Efficacy and Safety of Tocilizumab for TAO

NCT ID: NCT06087731

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-23

Study Completion Date

2023-09-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Tocilizumab Thyroid Associated Ophthalmopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tocilizumab

administrated with tocilizumab (8mg/kg) every four weeks

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

Tocilizumab (8mg/kg) every 4 wekks

Interventions

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Tocilizumab

Tocilizumab (8mg/kg) every 4 wekks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Dan Liang

Dan Liang

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Liang

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2023TAOIL-6

Identifier Type: -

Identifier Source: org_study_id