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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02846961

Acronym

OACIS

Enrollment

280

Registered

2016-07-27

Start date

2016-07-31

Completion date

2020-12-31

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis

Keywords

inflammatory bowel disease, biosimilar, anti-drug antibody, trough drug concentration

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion criteria

* Tuberculosis infection * Allergy to CT-P13

Design outcomes

Primary

Measure	Time frame
Development of anti-drug antibody to CT-P13	one year

Secondary

Measure	Time frame
Change of drug trough concentration	one year

Countries

South Korea

Outcome results