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NCT00095173 · ClinicalTrials.gov registry record · Phase 3
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT00095173: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00095173 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095173, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study Summary
The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.
Primary Outcome
Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed. All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints m
Interventions
- DRUG Placebo
- DRUG Abatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2003-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT00095173 record still lists
NCT00095173 is an interventional study that assigns participants to a tested intervention. The registered 214 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 (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00095173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00095173 about?
NCT00095173 is a clinical study titled "BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis". The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopa...
What is the current status of trial NCT00095173?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2003-12. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00095173?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT00095173?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00095173's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 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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