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NCT00048542 · ClinicalTrials.gov registry record · Phase 3
Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 171
- Enrollment target
NCT00048542: Completed Phase 3 study, sponsored by Abbott.
NCT00048542 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 171 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048542, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 171 participants
- Enrollment target
Study Summary
This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.
Primary Outcome
The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) \>= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) \>= 30% improvement in not more
Interventions
- BIOLOGICAL Double-Blind Adalimumab/Placebo + MTX
- BIOLOGICAL Double-Blind Adalimumab/Placebo
- DRUG OLE BSA Adalimumab +/- MTX
- DRUG OLE FD Adalimumab +/- MTX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2002-09 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00048542 record still lists
NCT00048542 is an interventional study that assigns participants to a tested intervention. The registered 171 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 (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Double-Blind Adalimumab/Placebo + MTX is the first listed.
NCT00048542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048542 about?
NCT00048542 is a clinical study titled "Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)". This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.
What is the current status of trial NCT00048542?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 171 participants. The study started on 2002-09. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00048542?
The interventions under investigation include: Double-Blind Adalimumab/Placebo + MTX (BIOLOGICAL), Double-Blind Adalimumab/Placebo (BIOLOGICAL), OLE BSA Adalimumab +/- MTX (DRUG), OLE FD Adalimumab +/- MTX (DRUG).
Who is sponsoring clinical trial NCT00048542?
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 NCT00048542's enrollment target sits among peer trials
171 1451st of 2000 higher than 548 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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