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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: Completed Phase 2 study, sponsored by Amgen.
NCT01868997 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
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"
Primary Outcome
Number of participants classified as responders and non-responders at Week 24. Responders were defined as participants with a reduction in clinical activity score (CAS, see Outcome Measure 4 description for details) of ≥ 2 points, and a reduction in proptosis (amount of protrusion of the eye from the orbital rim) of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye. Participants who had no assessment at 24 weeks
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 |
What the finished NCT01868997 record still lists
NCT01868997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which normal saline is the first listed.
NCT01868997 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01868997's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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