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NCT00547521 · ClinicalTrials.gov registry record · Phase 3
Phase IIIB Subcutaneous Abatacept Monotherapy Study
A Phase 3 study of Rheumatoid Arthritis (RA), sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT00547521: Completed Phase 3 study of Rheumatoid Arthritis (RA), sponsored by Bristol-Myers Squibb.
NCT00547521 is a Phase 3 study of Rheumatoid Arthritis (RA) that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 119 participants, below the 261-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00547521, a Phase 3 study of Rheumatoid Arthritis (RA), has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept
Primary Outcome
ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The
Conditions Studied
Interventions
- DRUG Methotrexate (MTX)
- DRUG abatacept
Study Locations (20)
Alabama
- Rheumatology Associates Of North Alabama - Huntsville
- Coastal Clinical Research Inc - Mobile
Pennsylvania
- East Penn Rheumatology Associates - Bethlehem
- Altoona Center For Clinical Research - Duncansville
South Carolina
- Low Country Rheumatology, Pa - Charleston
- Columbia Arthritis Center - Columbia
California
- Stanford University School Of Medicine - Palo Alto
Colorado
- Boulder Medical Center - Boulder
Florida
- The Arthritis Center - Palm Harbor
Kentucky
- Medical Towers South - Louisville
Nebraska
- Westroads Medical Group - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2007-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT00547521 record still lists
NCT00547521 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 261-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Rheumatoid Arthritis (RA) appearing as the primary indexed condition, and to 2 interventions - of which Methotrexate (MTX) is the first listed.
NCT00547521 names 20 study sites across 17 states, led by Alabama, Pennsylvania, South Carolina.
Frequently Asked Questions
What is clinical trial NCT00547521 about?
NCT00547521 is a clinical study titled "Phase IIIB Subcutaneous Abatacept Monotherapy Study". To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept
What is the current status of trial NCT00547521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2007-12. Estimated completion is 2014-02.
What conditions does trial NCT00547521 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis (RA).
What interventions are being tested in trial NCT00547521?
The interventions under investigation include: Methotrexate (MTX) (DRUG), abatacept (DRUG).
Who is sponsoring clinical trial NCT00547521?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00547521 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rheumatoid Arthritis (RA)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00547521's enrollment target sits among peer trials
119 8th of 17 higher than 10 of 17 other Rheumatoid Arthritis (RA) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis (RA) 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.
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