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NCT01439204 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
A Phase 1 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 223
- Enrollment target
- 1
- Study location
NCT01439204: Completed Phase 1 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
NCT01439204 is a Phase 1 study of Rheumatoid Arthritis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 223 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439204, a Phase 1 study of Rheumatoid Arthritis, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 223 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects
Primary Outcome
Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).
Conditions Studied
Interventions
- BIOLOGICAL Abatacept (BMS-188667)
Study Locations (1)
Nebraska
- Icon Clinical Pharmacology Unit, Llc - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT01439204 record still lists
NCT01439204 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Abatacept (BMS-188667) is the first listed.
NCT01439204 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT01439204 about?
NCT01439204 is a clinical study titled "Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb". The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects
What is the current status of trial NCT01439204?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 223 participants. The study started on 2011-10. Estimated completion is 2012-02.
What conditions does trial NCT01439204 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT01439204?
The interventions under investigation include: Abatacept (BMS-188667) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01439204?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01439204 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01439204's enrollment target sits among peer trials
223 79th of 197 higher than 119 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis 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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