Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease

Completed

Conditions studied: Inflammatory Bowel Disease (IBD), Crohn's Disease (CD), Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT03801928

Run by

Pfizer

People needed

118

Starts

2018-02-23

Expected to finish

2020-02-07

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• San Diego Clinical Trials — San Diego, California, United States
• Medical Research Center Of Connecticut, LLC — Hamden, Connecticut, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• Illinois Gastroenterology Group — Gurnee, Illinois, United States
• Indiana University Health Division of Gastroenterology/Hepatology — Indianapolis, Indiana, United States
• Gastro Center of Maryland — Columbia, Maryland, United States
• Infusion Associates N.E. — Grand Rapids, Michigan, United States
• Trinity Health Center Medical Arts — Minot, North Dakota, United States
• Dayton Gastroenterology, Inc. — Beavercreek, Ohio, United States
• Paramount Medical Research & consulting, LLC — Middleburg Heights, Ohio, United States
• The Vancouver Clinic Research — Vancouver, Washington, United States
• Aspen Woods Clinic — Calgary, Alberta, Canada
• Brennan Walters Professional Corporation — Edmonton, Alberta, Canada
• Fraser Clinical Trials — New Westminster, British Columbia, Canada
• Montreal IBD Center (CMIIM) — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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