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NCT01212770 · ClinicalTrials.gov registry record · Phase 3
PALACE 3: 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
- 505
- Enrollment target
NCT01212770: Completed Phase 3 study, sponsored by Amgen.
NCT01212770 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 505 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212770, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 505 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 and a qualifying psoriasis lesion. 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 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 assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a 10
Interventions
- DRUG Placebo
- DRUG Apremilast 30mg
- DRUG Apremilast 20mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 2010-09-30 |
| Est. Completion | 2017-02-09 |
| Phase | Phase 3 |
What the finished NCT01212770 record still lists
NCT01212770 is an interventional study that assigns participants to a tested intervention. The registered 505 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 (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01212770 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01212770 about?
NCT01212770 is a clinical study titled "PALACE 3: 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 and a qualifying psoriasis lesion. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function...
What is the current status of trial NCT01212770?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 505 participants. The study started on 2010-09-30. Estimated completion is 2017-02-09.
What interventions are being tested in trial NCT01212770?
The interventions under investigation include: Placebo (DRUG), Apremilast 30mg (DRUG), Apremilast 20mg (DRUG).
Who is sponsoring clinical trial NCT01212770?
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 NCT01212770's enrollment target sits among peer trials
505 742nd of 2000 higher than 1,259 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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