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NCT01583374 · ClinicalTrials.gov registry record · Phase 3
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
NCT01583374: Completed Phase 3 study, sponsored by Amgen.
NCT01583374 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 490 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
NCT01583374, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
Study Summary
Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.
Primary Outcome
ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: 1. Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale \[NRS\]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active 2. To
Interventions
- DRUG Placebo
- DRUG Apremilast tablet 20 mg
- DRUG Apremilast tablet 30 mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2012-05-02 |
| Est. Completion | 2018-10-25 |
| Phase | Phase 3 |
What the finished NCT01583374 record still lists
NCT01583374 is an interventional study that assigns participants to a tested intervention. The registered 490 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 3 interventions - of which Placebo is the first listed.
NCT01583374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01583374 about?
NCT01583374 is a clinical study titled "Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis". Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.
What is the current status of trial NCT01583374?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2012-05-02. Estimated completion is 2018-10-25.
What interventions are being tested in trial NCT01583374?
The interventions under investigation include: Placebo (DRUG), Apremilast tablet 20 mg (DRUG), Apremilast tablet 30 mg BID (DRUG).
Who is sponsoring clinical trial NCT01583374?
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 NCT01583374's enrollment target sits among peer trials
490 782nd of 2000 higher than 1,218 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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