Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03669029
Status:
UNKNOWN
Last Update Posted:
2018-09-13
First Post:
2018-07-04
Brief Title:
Optimization of Golimumab Treatment in Ulcerative Colitis
Sponsor:
Hospital de Manises
Organization:
Hospital de Manises
Study Overview
Official Title:
Optimization of Golimumab Treatment in Ulcerative Colitis
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_RECRUITING
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:
This is a multicenter prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment naïve to anti-TNF or after failure or exposure to one anti-TNF which aims to analyze serum golimumab levels and anti- golimumab antibody ADA levels during the induction week 6 and maintenance phases week 14 30 and 54 and correlate them with efficacy parameters
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None