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

Kyungpook National University Hospital280 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

280

Conditions

Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of Crohn's disease or ulcerative colitis Exclusion Criteria: * Tuberculosis infection * Allergy to CT-P13

Locations (1)

Kyungpook National University Hospital

Daegu, South Korea

Outcomes

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

Data from ClinicalTrials.gov

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