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

NCT02539368 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2565

Last updated 2020-02-13

Study results available
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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

Conditions

Interventions

DRUG

CT-P13

biosimilar infliximab

DRUG

Remicade

infliximab

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-22
Primary Completion
2018-10-31
Completion
2018-10-31
FDA Drug
Yes

Countries

  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539368 on ClinicalTrials.gov