NCT02846961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

July 23, 2016

Last Update Submit

February 15, 2021

Conditions

Inflammatory Bowel DiseaseUlcerative ColitisCrohn's Disease

Keywords

inflammatory bowel diseasebiosimilaranti-drug antibodytrough drug concentration

Outcome Measures

Primary Outcomes (1)

  • Development of anti-drug antibody to CT-P13

    one year

Secondary Outcomes (1)

  • Change of drug trough concentration

    one year

Study Arms (2)

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

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of Crohn's disease or ulcerative colitis

You may not qualify if:

  • Tuberculosis infection
  • Allergy to CT-P13

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Dong Il Park, MD

    Sungkyunkwan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2016

First Posted

July 27, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2019

Study Completion

December 1, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

KR(1)