Status:
COMPLETED
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
Lead Sponsor:
Amgen
Conditions:
Thyroid Associated Ophthalmopathies
Thyroid-Associated Ophthalmopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison t...
Detailed Description
Study with completed results acquired from Horizon in 2024.
Eligibility Criteria
Inclusion
- Clinical diagnosis of Graves' disease associated with active TED and a clinical activity score of ≥ 4
- Fewer than 9 months from onset of TED
- No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization
- Euthyroid or with mild hypo or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits (every effort should be made to correct the mild hypo- or hyperthyroidism promptly)
Exclusion
- Optic neuropathy
- Corneal decompensation unresponsive to medical management
- Oral or IV steroid treatment for any non-TED reason in the preceding 3 months
- Poorly controlled diabetes
- Platelets \< 100 x 10\^9/L
- Hemoglobin concentration \> 2 g/dL below the lower limit of normal
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2017
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01868997
Start Date
July 1 2013
End Date
February 22 2017
Last Update
December 17 2024
Active Locations (15)
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1
Jules Stein Eye Institute at UCLA
Los Angeles, California, United States, 90095
2
University of Denver
Aurora, Colorado, United States, 80045
3
Emory University Department of Ophthalmology
Atlanta, Georgia, United States, 30322
4
University of Iowa Hospitals and Clinics, Department of Ophthalmology
Iowa City, Iowa, United States, 52242