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NCT00119678 · ClinicalTrials.gov registry record · Phase 2
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT00119678: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT00119678 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00119678, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
Primary Outcome
SLE flares scored using BILAG:A:presence of =\>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/part
Interventions
- DRUG Placebo
- DRUG Abatacept
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
What the finished NCT00119678 record still lists
NCT00119678 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00119678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00119678 about?
NCT00119678 is a clinical study titled "Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone". The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of ...
What is the current status of trial NCT00119678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2005-09. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00119678?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT00119678?
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 NCT00119678's enrollment target sits among peer trials
183 363rd of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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