Actively Recruiting
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Led by Walter Reed National Military Medical Center · Updated on 2024-02-23
100
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical outcomes of patients with active thyroid eye disease (TED), a rare autoimmune condition that affects the eye muscles and tissues, causing symptoms like proptosis, pain, double vision, and swelling. The study focuses on adults with moderate to severe TED who show signs such as pain, diplopia, eyelid or orbital swelling, and redness. The condition can significantly impact vision and quality of life, and this research aims to assess treatment outcomes under medical supervision. The treatment under observation is teprotumumab (Tepezza®), a monoclonal antibody that targets the underlying inflammatory process in TED. Patients recommended for this infusion therapy will be evaluated by specialists including an oculoplastic surgeon and an endocrinologist. The study involves a retrospective review of medical records for adults without urgent optic nerve compression requiring surgery or radiation. The treatment period and follow-up span 6 to 12 months post-treatment to observe clinical activity and antibody levels. Participants will undergo clinical activity scoring and thyroid stimulating immunoglobulin testing between 6 and 12 months after treatment. Researchers will also analyze HLA subtypes to explore their relationship with treatment response. The study involves detailed monitoring of symptoms such as proptosis and diplopia, with safety considerations excluding patients with uncontrolled diabetes, inflammatory bowel disease, or pregnancy. Participation includes regular evaluations and laboratory testing to track disease activity and immune markers over time.
CONDITIONS
Brief Title
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Only Department of Defense beneficiaries
- Adults aged 18 years or older
- Adults with proptosis, eye or orbital pain, double vision, eyelid or orbital swelling, or eyelid or orbital redness associated with autoimmune thyroid disease
You will not qualify if you...
- Patients with compressive optic neuropathy requiring urgent orbital decompression or radiation therapy
- Patients with a history of uncontrolled diabetes mellitus
- Patients diagnosed with uncontrolled inflammatory bowel disease
- Patients under 18 years of age
- Patients who are pregnant or trying to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive teprotumumab injections to treat thyroid eye disease by blocking the underlying autoimmune process.
Weekly visits for up to 24 weeks
Duration - 6 to 12 months post treatment
Participants are monitored for clinical activity score improvement, thyroid stimulating immunoglobulin levels, and HLA subtype correlations after treatment ends.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 1 location
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Actively Recruiting
Research Team
T
THANH D HOANG, DO
I
Iris Morris, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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