CClinicalTrials.gg
CompletedNCT02846961OACISUpdated Feb 16, 2021

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

An observational study in Inflammatory Bowel Disease, Ulcerative Colitis and Crohn's Disease, sponsored by Kyungpook National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Kyungpook National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Crohn's Disease

Keywords

  • inflammatory bowel disease
  • biosimilar
  • anti-drug antibody
  • trough drug concentration
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 280 is above the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 76 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion criteria

Exclusion Criteria:

  • Tuberculosis infection
  • Allergy to CT-P13
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Development of anti-drug antibody to CT-P13

    Time frame: one year

Secondary outcomes

  1. Change of drug trough concentration

    Time frame: one year

07

Study locations

1 site
  • Kyungpook National University Hospital
    Daegu, 41944, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02846961
Lead sponsor
Kyungpook National University Hospital
Responsible party
Eun Soo Kim, MD, PhD (Professor, Kyungpook National University Hospital) — Principal investigator
First posted
Jul 27, 2016
Start date
Jul 2016
Primary completion
Sep 2019
Completion
Dec 2020
Last update
Feb 16, 2021

Study contacts

Dong Il Park, MD
study chair · Sungkyunkwan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion