Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-02-02 @ 11:20 AM
Study NCT ID:
NCT02846961
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2016-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease
Sponsor:
Kyungpook National University Hospital
Organization:
Study Overview
Official Title:
Occurrence of Anti-drug Antibody and Change of Drug Level for 1 Year After CT-P13 Therapy and Their Impact on Clinical Outcomes in Moderate to Severe Inflammatory Bowel Disease (OACIS Study)
Status:
COMPLETED
Status Verified Date:
2021-02
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:
OACIS
Brief Summary:
The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.
Detailed Description:
None
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?: