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

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.

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion criteria

Tuberculosis infection
Allergy to CT-P13

Treatment and study plan

Primary outcomes

Development of anti-drug antibody to CT-P13

Time frame: one year

Secondary outcomes

Change of drug trough concentration

Time frame: one year

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study 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)

Acronym: OACIS

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Jul 27, 2016
Registry last updated: Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed