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NCT01285310 · ClinicalTrials.gov registry record · Phase 2
Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis
A Phase 2 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 237
- Enrollment target
NCT01285310: Clinical Trial Phase 2 study, sponsored by Amgen.
NCT01285310 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285310, a Phase 2 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 237 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 rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.
Primary Outcome
Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); Subject's global assessment of disease activity (measur
Interventions
- DRUG Placebo
- DRUG Apremilast 30 mg
- DRUG Apremilast 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2010-12-09 |
| Est. Completion | 2012-09-10 |
| Phase | Phase 2 |
Why NCT01285310 stopped before completion
NCT01285310 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01285310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01285310 about?
NCT01285310 is a clinical study titled "Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis". The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who h...
What is the current status of trial NCT01285310?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2010-12-09. Estimated completion is 2012-09-10.
What interventions are being tested in trial NCT01285310?
The interventions under investigation include: Placebo (DRUG), Apremilast 30 mg (DRUG), Apremilast 20 mg (DRUG).
Who is sponsoring clinical trial NCT01285310?
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 NCT01285310's enrollment target sits among peer trials
237 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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