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NCT00195494 · ClinicalTrials.gov registry record · Phase 4
Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
A Phase 4 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 542
- Enrollment target
NCT00195494: Completed Phase 4 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00195494 is a Phase 4 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 542 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195494, a Phase 4 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 542 participants
- Enrollment target
Study Summary
To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.
Primary Outcome
Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 542 participants |
| Start Date | 2004-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 4 |
What the finished NCT00195494 record still lists
NCT00195494 is an interventional study that assigns participants to a tested intervention. The registered 542 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00195494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00195494 about?
NCT00195494 is a clinical study titled "Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis". To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.
What is the current status of trial NCT00195494?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 542 participants. The study started on 2004-11. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00195494?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT00195494?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00195494's enrollment target sits among peer trials
542 157th of 2000 higher than 1,844 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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