Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-28 @ 8:46 AM
Study NCT ID:
NCT01844895
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2013-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methotrexate-Inadequate Response Autoinjector Device Sub Study
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
Substudy-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTX-IR
Brief Summary:
The purpose of this study is to implement a substudy in approximately 120 rheumatoid arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC) Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled syringe.
Detailed Description:
Study Classification:
* Safety: show if the drug is safe under conditions of proposed use
* Efficacy: measure of an intervention's influence on a disease or health condition
* Safety/Efficacy
* Pharmacokinetics: the action of a drug in the body over a period of time including the process of absorption, distribution and localization in tissue, biotransformation, and excretion of the compound.
* Safety: show if the drug is safe under conditions of proposed use
* Efficacy: measure of an intervention's influence on a disease or health condition
* Safety/Efficacy
* Pharmacokinetics: the action of a drug in the body over a period of time including the process of absorption, distribution and localization in tissue, biotransformation, and excretion of the compound.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-005434-37 | EUDRACT_NUMBER | None | View |