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NCT00259610 · ClinicalTrials.gov registry record · Phase 4
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 755
- Enrollment target
NCT00259610: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT00259610 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 755 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00259610, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 755 participants
- Enrollment target
Study Summary
The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better
Primary Outcome
Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* GH. The ESR is the rate at which red blood cells sediment in a period of one hour. The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the curr
Interventions
- DRUG methotrexate
- DRUG hydroxychloroquine
- DRUG etanercept
- DRUG sulfasalazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 755 participants |
| Start Date | 2004-05 |
| Est. Completion | 2009-06 |
| Phase | Phase 4 |
What the finished NCT00259610 record still lists
NCT00259610 is an interventional study that assigns participants to a tested intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 4 interventions - of which methotrexate is the first listed.
NCT00259610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00259610 about?
NCT00259610 is a clinical study titled "Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)". The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone an...
What is the current status of trial NCT00259610?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 755 participants. The study started on 2004-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00259610?
The interventions under investigation include: methotrexate (DRUG), hydroxychloroquine (DRUG), etanercept (DRUG), sulfasalazine (DRUG).
Who is sponsoring clinical trial NCT00259610?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00259610's enrollment target sits among peer trials
755 106th of 2000 higher than 1,895 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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