Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01172938 · ClinicalTrials.gov registry record · Phase 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
- 504
- Enrollment target
NCT01172938: Completed Phase 3 study, sponsored by Amgen.
NCT01172938 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 504 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
NCT01172938, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 504 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, specifically in improving 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 Apremilast 30mg
- DRUG Apremilast 20mg
- DRUG Placebo + 20 mg Apremilast
- DRUG Placebo + 30 mg Apremilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2010-06-02 |
| Est. Completion | 2016-10-27 |
| Phase | Phase 3 |
What the finished NCT01172938 record still lists
NCT01172938 is an interventional study that assigns participants to a tested intervention. The registered 504 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 4 interventions - of which Apremilast 30mg is the first listed.
NCT01172938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01172938 about?
NCT01172938 is a clinical study titled "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, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
What is the current status of trial NCT01172938?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2010-06-02. Estimated completion is 2016-10-27.
What interventions are being tested in trial NCT01172938?
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 NCT01172938?
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 NCT01172938's enrollment target sits among peer trials
504 742nd of 2000 higher than 1,258 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05846282 · 504 participants · NA
Students Rising Above: Offsetting the Health and Mental Health Costs of Resilience
- NCT06072131 · 504 participants · Phase 3
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
- NCT06736522 · 504 participants · NA
Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program
- NCT06822257 · 504 participants · NA
Drinking in Young Adult Duos (DYAD) Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI