Overview

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

Status:
Completed
Trial end date:
2018-10-31
Target enrollment:
0
Participant gender:
All
Summary
This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborators:
Hospira, Inc.
Hospira, now a wholly owned subsidiary of Pfizer
Treatments:
Infliximab
Criteria
Inclusion Criteria:

1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at
least 18 years of age at the time of enrolment to the study.

2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC
prescribed according to the corresponding summary of product characteristics (SmPC) as
determined by the Investigator. Patients with stomas or surgery/pouch will be
included.

Exclusion Criteria:

1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.

2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its
excipients or other murine proteins, at the time of enrolment.

3. Prior history of failure to respond to Remicade or CT-P13.