Efficacy and Safety of Tocilizumab for TAO

NCT06087731 | Withdrawn Phase 2 DMC

• 1 other identifier: 2023TAOIL-6
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tocilizumab; Thyroid Associated Ophthalmopathy

Keywords

Thyroid Associated Ophthalmopathy; tocilizumab

Outcome Measures

Primary Outcomes (6)

• volume and signal intensity of each extraocular muscles and soft tissue in MRI images

  The volume and signal intensity of each extraocular muscles and soft tissue are analyzed in the MRI slides of each patients. each part of each extraocular muscles and soft tissue were measured three times and two trained performers will do this assignment respectively.

  month 1，month 3，month 6

• Clinical Activity Score

  Spontaneous orbital pain. Gaze evoked orbital pain. Eyelid swelling that is considered to be due to active (inflammatory phase) GO. Eyelid erythema. Conjunctival redness that is considered to be due to active (inflammatory phase) GO (ignore "equivocal" redness). Chemosis. Inflammation of caruncle or plica

  month 1，month 3，month 6

• eyelid aperture

  For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. When performed this assessment, participants should relax their eyes and keep looking ahead and the observers should keep the ruler perpendicular to their eyelid.

  month 1，month 3，month 6

• exophthalmos

  For the assessment of exophthalmos, the same Hertel instrument and ideally the same observer should be used on each occasion. Additionally the same intercanthal distance (ICD) should be used on each occasion.

  month 1，month 3，month 6

• eyelid lag

  For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. Lid lag is defined that the lid margin distance in downgaze. The upper eyelid positions above (recorded '+') or below (recorded '-') the superior limbus will be measured in millimeters.

  month 1，month 3，month 6

• retraction of the upper and lower eyelids

  For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. The upper eyelid positions above (recorded '+') or below (recorded '-') the superior limbus and the lower eyelid positions above (recorded '+') or below (recorded '-') the posterior limbus will be measured in millimeters on the primary position with relaxed status.

  month 1，month 3，month 6

Secondary Outcomes (3)

• ocular motility

  month 1，month 3，month 6

• Graves' Ophthalmopathy Quality of Life Scale

  month 1，month 3，month 6

• inflammatory markers changes

  month 1，month 3，month 6

Study Arms (1)

tocilizumab

EXPERIMENTAL

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

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Tocilizumab (8mg/kg) every 4 wekks

tocilizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dan Liang

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan Liang

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 18, 2023
• Study Start: September 23, 2023
• Primary Completion: September 23, 2023
• Study Completion: September 23, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)