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NCT02846961 Clinical Trial

Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— OACIS  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02846961
Other study ID # KMU160306
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2016
Est. completion date December 2020

Study information
Verified date February 2021
Source Kyungpook National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 280
Est. completion date December 2020
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Crohn's disease or ulcerative colitis Exclusion Criteria: - Tuberculosis infection - Allergy to CT-P13

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (1)
Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of anti-drug antibody to CT-P13 one year
Secondary Change of drug trough concentration one year
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