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NCT01212757 · ClinicalTrials.gov registry record · Phase 3
PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
NCT01212757: Completed Phase 3 study, sponsored by Amgen.
NCT01212757 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 488 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212757, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
Primary Outcome
Percentage of participants with an 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 assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦Physician's global assessment
Interventions
- DRUG Apremilast 30mg
- DRUG Apremilast 20mg
- DRUG Placebo + 20 mg Apremilast
- DRUG Placebo + 30 mg Apremilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2010-09-27 |
| Est. Completion | 2017-01-25 |
| Phase | Phase 3 |
What the finished NCT01212757 record still lists
NCT01212757 is an interventional study that assigns participants to a tested intervention. The registered 488 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 (37% lower).
The record links to 0 conditions, and to 4 interventions - of which Apremilast 30mg is the first listed.
NCT01212757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01212757 about?
NCT01212757 is a clinical study titled "PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis". The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
What is the current status of trial NCT01212757?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2010-09-27. Estimated completion is 2017-01-25.
What interventions are being tested in trial NCT01212757?
The interventions under investigation include: Apremilast 30mg (DRUG), Apremilast 20mg (DRUG), Placebo + 20 mg Apremilast (DRUG), Placebo + 30 mg Apremilast (DRUG).
Who is sponsoring clinical trial NCT01212757?
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 NCT01212757's enrollment target sits among peer trials
488 784th of 2000 higher than 1,215 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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