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

February 15, 2021 updated by: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital

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)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with moderate to severe inflammatory bowel disease who need to receive biosimilar CT-P13

Description

Inclusion Criteria:

  • Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion Criteria:

  • Tuberculosis infection
  • Allergy to CT-P13

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Crohn's disease
Patients with moderate to severe Crohn's disease who need to get a biosimilar CT-P13
Ulcerative colitis
Patients with moderate to severe ulcerative colitis who need to get a biosimilar CT-P13

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of anti-drug antibody to CT-P13
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of drug trough concentration
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Study Chair: Dong Il Park, MD, Sungkyunkwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

July 23, 2016

First Submitted That Met QC Criteria

July 23, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU160306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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