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NCT01313208 · ClinicalTrials.gov registry record · Phase 4
Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 210
- Enrollment target
NCT01313208: Completed Phase 4 study, sponsored by Amgen.
NCT01313208 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 210 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313208, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 210 participants
- Enrollment target
Study Summary
This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).
Primary Outcome
Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all)
Interventions
- DRUG Placebo
- DRUG etanercept
- DRUG DMARD Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
What the finished NCT01313208 record still lists
NCT01313208 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01313208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313208 about?
NCT01313208 is a clinical study titled "Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)". This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).
What is the current status of trial NCT01313208?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 210 participants. The study started on 2011-03. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01313208?
The interventions under investigation include: Placebo (DRUG), etanercept (DRUG), DMARD Therapy (DRUG).
Who is sponsoring clinical trial NCT01313208?
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 NCT01313208's enrollment target sits among peer trials
210 398th of 2000 higher than 1,602 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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