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NCT00420927 · ClinicalTrials.gov registry record · Phase 4
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
A Phase 4 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,032
- Enrollment target
NCT00420927: Completed Phase 4 study, sponsored by Abbott.
NCT00420927 is a Phase 4 study that has completed, run by Abbott. The registered enrollment target is 1,032 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00420927, a Phase 4 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,032 participants
- Enrollment target
Study Summary
This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).
Primary Outcome
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are adde
Interventions
- BIOLOGICAL placebo
- DRUG methotrexate
- BIOLOGICAL adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,032 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-07 |
| Phase | Phase 4 |
What the finished NCT00420927 record still lists
NCT00420927 is an interventional study that assigns participants to a tested intervention. Its 1,032 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% higher).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00420927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00420927 about?
NCT00420927 is a clinical study titled "Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis". This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).
What is the current status of trial NCT00420927?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,032 participants. The study started on 2006-12. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00420927?
The interventions under investigation include: placebo (BIOLOGICAL), methotrexate (DRUG), adalimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00420927?
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 NCT00420927's enrollment target sits among peer trials
1,032 66th of 2000 higher than 1,935 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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