Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Participants in this arm will receive the full standard-of-care course of Teprotumumab. This consists of a total of 8 intravenous (IV) infusions. |
|
| Shortened Treatment | Experimental | Participants in this arm will receive a shortened course of Teprotumumab. After demonstrating an "Early Optimal Clinical Response" following the first 4 infusions, treatment will be discontinued. These participants will receive a total of 4 intravenous (IV) infusions instead of the standard 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teprotumumab Injection [Tepezza] | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Defined as a reduction of 2 or more points in the Clinical Activity Score (CAS), improvement in diplopia and exophthalmos. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
Not provided
Not provided
| ID | Term |
|---|---|
| C551399 | teprotumumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |