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NCT01925768 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT01925768: Completed Phase 3 study, sponsored by Amgen.
NCT01925768 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925768, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.
Primary Outcome
Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in 78 tender joint count; * ≥ 20% improvement in 76 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \[NRS\]); * Patient's global self-assessment of disease act
Interventions
- DRUG Placebo
- DRUG Apremilast 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2013-09-04 |
| Est. Completion | 2016-11-17 |
| Phase | Phase 3 |
What the finished NCT01925768 record still lists
NCT01925768 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01925768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01925768 about?
NCT01925768 is a clinical study titled "Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis". The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.
What is the current status of trial NCT01925768?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2013-09-04. Estimated completion is 2016-11-17.
What interventions are being tested in trial NCT01925768?
The interventions under investigation include: Placebo (DRUG), Apremilast 30 mg (DRUG).
Who is sponsoring clinical trial NCT01925768?
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 NCT01925768's enrollment target sits among peer trials
219 1329th of 2000 higher than 670 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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