The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

NCT06275373 | Recruiting FDA Drug

• 1 other identifier: 20-10974
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).

Conditions

Thyroid Eye Disease; Graves Ophthalmopathy; Graves Disease

Keywords

Thyroid eye disease; Graves ophthalmopathy; Graves disease

Outcome Measures

Primary Outcomes (2)

• Ophthalmological Clinical Activity Score (CAS) scoring

  CAS scoring (1 to 10)

  6-12 months post treatment

• Thyroid stimulating immunoglobulin

  TSI (IU/L)

  6-12 months post treatment

Secondary Outcomes (1)

• HLA subtypes

  6-12 months

Interventions

Teprotumumab Injection [Tepezza] DRUG

IGF1 monoclonal antibody

Also known as: Tepezza TM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study participants were 18-80 years old at the time of treatment with teprotumumab, diagnosed with autoimmune thyroid disease (positive stimulating thyroid receptor antibodies or elevated TSI), presenting with active eye disease (associated with at least one of the following: lid retraction of ≥2 mm, moderate or severe soft-tissue involvement, proptosis of ≥3 mm above the normal values for race and sex, and periodic or constant diplopia), and treated with at least one dose of teprotumumab.

You may qualify if:

• only DOD beneficiaries
• adult patients 18 years of age or older
• adult patients with proptosis, ocular/orbital pain, diplopia, lid/orbital edema, or lid/orbital erythema associated with autoimmune thyroid disease

You may not qualify if:

• Patients with evidence of compressive optic neuropathy necessitating urgent orbital decompression or external beam radiation
• patients with a history of uncontrolled diabetes mellitus
• patients with a history/diagnosis of uncontrolled inflammatory bowel disease
• patients under age 18 years
• patients who are pregnant or trying to become pregnant.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy; Graves Disease

Interventions

teprotumumab

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; 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

• Thanh D Hoang, DO

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

THANH D HOANG, DO

CONTACT

3012955165; thanh.d.hoang.mil@health.mil

Iris Morris, PhD

CONTACT

3013194599; iris.e.morris3.civ@health.mil

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 23, 2024
• Study Start: May 12, 2021
• Primary Completion (Estimated): May 12, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)