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NCT00647270 · ClinicalTrials.gov registry record · Phase 3
Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
NCT00647270: Completed Phase 3 study, sponsored by Abbott.
NCT00647270 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 420 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00647270, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
Study Summary
To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.
Primary Outcome
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a hea
Interventions
- DRUG Placebo
- DRUG adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00647270 record still lists
NCT00647270 is an interventional study that assigns participants to a tested intervention. The registered 420 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 (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00647270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00647270 about?
NCT00647270 is a clinical study titled "Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing". To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.
What is the current status of trial NCT00647270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2007-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00647270?
The interventions under investigation include: Placebo (DRUG), adalimumab (DRUG).
Who is sponsoring clinical trial NCT00647270?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00647270's enrollment target sits among peer trials
420 891st of 2000 higher than 1,102 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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