Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410410
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2006-12-11
Brief Title:
A Study of Abatacept in Patients With Active Ulcerative Colitis
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase 3 Multi-Center Randomized Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis UC Who Have Had an Inadequate Clinical Response andor Intolerance to Medical Therapy
Status:
COMPLETED
Status Verified Date:
2015-03
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:
None
Brief Summary:
The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies The safety of this treatment will also be studied
Detailed Description:
The Induction Period First Cohort IP1C arms 3010 mgkg and 10 mgkg were placebo-controlled arms that were used for the primary endpoint and its analysis The Induction Period Second Cohort arms IP2C 3010 mgkg and 10 mgkg were not placebo-controlled their sole purpose being to provide sufficient numbers of participants for the maintenance phase The first cohort IP1C was randomized to receive placebo or 1 of 3 doses of abatacept Following completion of the IP1C randomization a second cohort IP2C was randomized to receive 1 of 2 doses of abatacept After all participants in the IP1C completed or discontinued the data was locked and the formal analysis for the Induction Period primary endpoint was performed Summary tables for the second cohort IP2C and the Maintenance and Open-label phases were generated from a second subsequent data lock
Study Oversight
Has Oversight DMC:
None
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?:
None