Clinical Trial: Teprotumumab Treatment in Patients With Active Thyroid Eye Disease
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicenter, Double-masked, Placebo-controlled, Efficacy and Safety Study of an Insulin-like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), in Patients With Active
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and effectiveness of a fully human antibody compared to placebo in the treatment of patients with active thyroid eye disease.
"Funding Source - FDA OOPD"
Detailed Summary: A multicenter, double-masked, placebo-controlled, efficacy and safety study of RV 001, an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody (fully human), administered every 3 weeks (q3W) by intravenous (iv) infusion in patients suffering from active thyroid eye disease (TED)
Sponsor: River Vision Development Corporation
Current Primary Outcome: Responder Analysis - Patients are considered responders if their Week 24 Clinical Activity Score decreases ≥ 2 points AND Proptosis decreases of ≥ 2 mm. [ Time Frame: 6 months ]
Original Primary Outcome: Clinical Activity Score [ Time Frame: 6 months ]
Current Secondary Outcome:
- GO-Quality of Life [ Time Frame: 6 months ]
- Proptosis as a continuous variable [ Time Frame: 6 months ]
- Clinical Activity Score as a continuous variable [ Time Frame: 6 months ]
Original Secondary Outcome: Clinical Severity Score [ Time Frame: 6 months ]
Information By: River Vision Development Corporation
Dates:
Date Received: May 2, 2013
Date Started: July 2013
Date Completion: March 2018
Last Updated: March 20, 2017
Last Verified: March 2017
