Efficacy and Safety of Tocilizumab for TAO

Sun Yat-sen University

Status and phase: Withdrawn; Phase 2

Conditions: Thyroid Associated Ophthalmopathy; Tocilizumab

Treatments: Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06087731

2023TAOIL-6

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

tocilizumab

Experimental group

Description:

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

Treatment:

Drug: Tocilizumab