Columbia, Maryland 21045


Purpose:

This is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in the United States and Canada in which the participating physician has decided to treat with INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with INFLECTRA.


Criteria:

Inclusion Criteria: Patients must meet all of the following criteria to be eligible for inclusion in the study: 1. Patients with confirmed diagnosis of Ulcerative Colitis or Crohn's Disease. 2. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 3. Patient eligible to receive INFLECTRA for the treatment of their disease per approved drug label (patients with fistula, or stoma are eligible). Exclusion Criteria: -Patients meeting any of the following criteria will not be included in the study: 1. Patient previously failed treatment with REMICADE or INFLECTRA/CT P13. 2. Any reported contraindications for INFLECTRA/CT P13 or REMICADE. 3. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.


NCT ID:

NCT03801928


Primary Contact:

Study Director
Pfizer CT.gov Call Center
Pfizer

Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com


Backup Contact:

N/A


Location Contact:

Columbia, Maryland 21045
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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