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:
Participant gender:
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
Details
Lead Sponsor:
Pfizer
Collaborators:
Hospira, Inc. Hospira, now a wholly owned subsidiary of Pfizer