Status:
COMPLETED
Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
Lead Sponsor:
Pfizer
Conditions:
Inflammatory Bowel Disease (IBD)
Crohn's Disease (CD)
Eligibility:
All Genders
18+ years
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria to be eligible for inclusion in the study:
- Patients with confirmed diagnosis of Ulcerative Colitis or Crohn's Disease.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Patient eligible to receive INFLECTRA for the treatment of their disease per approved drug label (patients with fistula, or stoma are eligible).
Exclusion
- Patients meeting any of the following criteria will not be included in the study:
- Patient previously failed treatment with REMICADE or INFLECTRA/CT P13.
- Any reported contraindications for INFLECTRA/CT P13 or REMICADE.
- Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
Key Trial Info
Start Date :
February 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 7 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03801928
Start Date
February 23 2018
End Date
February 7 2020
Last Update
March 2 2021
Active Locations (15)
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1
San Diego Clinical Trials
San Diego, California, United States, 92120
2
Medical Research Center Of Connecticut, LLC
Hamden, Connecticut, United States, 06518
3
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
4
Illinois Gastroenterology Group
Gurnee, Illinois, United States, 60031