Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teprotumumab Injection [Tepezza].
- Who it may be relevant to
- Registry conditions: Thyroid Eye Disease, Thyroid Eye Disease, TED, Thyroid Eye Disease (TED). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response
Overview
The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED). The main question it aims to answer is: \* Is a shorter course equally effective and safe for patients who respond well early in treatment. Participants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.
Interventions
- Drug Teprotumumab Injection [Tepezza]
As a standard of care Teprotumumab is administered intravenously every 3 weeks for a total of 8 infusions (24 weeks). In the Shortened Arm participants receive a total of 4 infusions (12 weeks) provided they met the "Early Optimal Clinical Response" criteria at Week 12.
Primary outcome measures
- Clinical Response [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Participants must have a confirmed diagnosis of active Thyroid Eye Disease (TED).
- Participants must be eligible for and have started the standard Teprotumumab (Tepezza) treatment protocol.
- Participants must demonstrate a significant clinical response by the 4th infusion.
- Ability to understand and provide signed written informed consent.
Exclusion criteria
- Previous use of Teprotumumab or other biologic therapies for TED.
- Participants who do not show early clinical response after the 4th infusion.
- Participants who have any medical contraindications to Teprotumumab or any of its components.
- Participants who have any known hearing problems.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07308964 · SMC-2514-25