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NCT01890473 · ClinicalTrials.gov registry record · Phase 1
Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
A Phase 1 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 356
- Enrollment target
- 20
- Study locations
NCT01890473: Completed Phase 1 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
NCT01890473 is a Phase 1 study of Rheumatoid Arthritis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 356 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01890473, a Phase 1 study of Rheumatoid Arthritis, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 356 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.
Primary Outcome
Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (μg/mL). Blood samples for pharmacokinetic (PK) parameters were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.
Conditions Studied
Interventions
- DRUG Abatacept
Study Locations (20)
North Carolina
- Djl Research, Pllc - Charlotte
- Wake Research Associates - Raleigh
- Pmg Research Of Salisbury - Salisbury
- Pmg Research Of Wilmington Llc - Wilmington
Córdoba Province
- Local Institution - Córdoba
- Local Institution - Córdoba
Alabama
- Rheumatology Associates Of North Alabama, P.C. - Huntsville
Colorado
- Immunoe Int'L Research Ctrs - Centennial
Florida
- Covance Cru Inc - Daytona Beach
Kansas
- Heartland Research Associates, Llc - Wichita
Massachusetts
- Clinical Pharmacology Study Group - Worcester
Nebraska
- Physician Research Collaboration, Llc - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01890473 record still lists
NCT01890473 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (92% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Abatacept is the first listed.
NCT01890473 names 20 study sites across 16 states, led by North Carolina, Córdoba Province, Alabama.
Frequently Asked Questions
What is clinical trial NCT01890473 about?
NCT01890473 is a clinical study titled "Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe". The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.
What is the current status of trial NCT01890473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 356 participants. The study started on 2013-07. Estimated completion is 2014-11.
What conditions does trial NCT01890473 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT01890473?
The interventions under investigation include: Abatacept (DRUG).
Who is sponsoring clinical trial NCT01890473?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01890473 being conducted?
This trial has 20 study locations across Alabama, Colorado, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01890473's enrollment target sits among peer trials
356 51st of 197 higher than 147 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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