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

Completed

• Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

• Registration Number: NCT02846961
• Lead Sponsor: Kyungpook National University Hospital

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

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-23
• Study First Submitted QC: 2016-07-23
• Study First Posted: 2016-07-27
• Primary Completion: 2019-09
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion Criteria

• Tuberculosis infection
• Allergy to CT-P13

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of anti-drug antibody to CT-P13	one year

Secondary Outcome Measures

Name	Time	Method
Change of drug trough concentration	one year

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of