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NCT01868997 · ClinicalTrials.gov registry record · Phase 2
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT01868997 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 88 participants.
The verdict
NCT01868997, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study 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 to placebo, in the treatment of participants suffering from active TED. "Funding Source - FDA OOPD"
Interventions
- DRUG normal saline
- DRUG teprotumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-02-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01868997
The ClinicalTrials.gov registry entry for NCT01868997 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which normal saline is the first listed.
NCT01868997 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01868997 about?
NCT01868997 is a clinical study titled "Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease". 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 to placebo, in the treatment of participants suffering from active TED. "Funding Source - FDA OOPD"
What is the current status of trial NCT01868997?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2013-07. Estimated completion is 2017-02-22.
What interventions are being tested in trial NCT01868997?
The interventions under investigation include: normal saline (DRUG), teprotumumab (DRUG).
Who is sponsoring clinical trial NCT01868997?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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