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

Kyungpook National University

Status: Completed

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02846961

KMU160306

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion criteria

• Tuberculosis infection
• Allergy to CT-P13

Trial design

280 participants in 2 patient groups

Crohn's disease

Description:

Patients with moderate to severe Crohn's disease who need to get a biosimilar CT-P13

Ulcerative colitis

Description:

Patients with moderate to severe ulcerative colitis who need to get a biosimilar CT-P13