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NCT01400516 · ClinicalTrials.gov registry record · Phase 4
Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01400516: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01400516 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400516, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
Summary: The investigators propose a randomized controlled open label study of teriparatide in men or women with rheumatoid arthritis and joint erosions. Specifically, the investigators will examine whether teriparatide in combination with a biologic can retard the development of joint erosions. The study will be conducted at Brigham and Women's Hospital Arthritis Center, several Brigham and Women's Hospital Arthritis Center satellite practices, the University of Massachusetts Medical Center, and Massachusetts General Hospital. Hypothesis: The investigators hypothesize that the combination of teriparatide with biologic will be much more effective at retarding erosion progression then a biologic alone.
Primary Outcome
Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement.
Interventions
- DRUG Teriparatide
- DRUG Vitamin D
- DRUG calcium citrate
- DRUG TNF antagonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-07-28 |
| Phase | Phase 4 |
What the finished NCT01400516 record still lists
NCT01400516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Teriparatide is the first listed.
NCT01400516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01400516 about?
NCT01400516 is a clinical study titled "Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial". Summary: The investigators propose a randomized controlled open label study of teriparatide in men or women with rheumatoid arthritis and joint erosions. Specifically, the investigators will examine whether teriparatide in combination with a biologic can retard the development of joint erosions. Th...
What is the current status of trial NCT01400516?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2011-08. Estimated completion is 2016-07-28.
What interventions are being tested in trial NCT01400516?
The interventions under investigation include: Teriparatide (DRUG), Vitamin D (DRUG), calcium citrate (DRUG), TNF antagonist (DRUG).
Who is sponsoring clinical trial NCT01400516?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01400516's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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