Ignite Creation Date:
2024-05-06 @ 12:05 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01481142
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2011-11-24
Brief Title:
Adacolumn in Refractory UC Patients Trial
Sponsor:
Otsuka Pharmaceutical Europe Ltd
Organization:
Otsuka Pharmaceutical Europe Ltd
Study Overview
Official Title:
Multicentre Investigation of the Efficacy and Safety of Adacolumn GMA in Patients With Steroid-Dependent Active Ulcerative Colitis and Insufficient Response or Intolerance to Immunosuppressants andor Biological Therapies
Status:
COMPLETED
Status Verified Date:
2015-10
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:
ART
Brief Summary:
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments administered once weekly over 5 or more weeks in a specific subset of ulcerative colitis patients The patient subset of interest is those with moderatesevere steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants andor biological agents
Detailed Description:
None
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