NCT02846961

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
• Phase: —
• Study type: Observational
• Enrollment: 280 (actual)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-09-01
• Completion: 2020-12-01
• First posted: 2016-07-27
• Last updated: 2021-02-16

Locations

1 site across 1 country: South Korea