Clinical Trials Directory

Trials / Completed

CompletedNCT03801928

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

OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA

Status
Completed
Phase
Study type
Observational
Enrollment
118 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
DRUGInflectraThe study plans to recruit 300 subjects in the United States and Canada initiating or switching to treatment with INFLECTRA over an 8 month period. The decision to start INFLECTRA will be entirely a clinical decision made by the participating physician irrespective of this study.

Timeline

Start date
2018-02-23
Primary completion
2020-02-07
Completion
2020-02-07
First posted
2019-01-14
Last updated
2021-03-02
Results posted
2021-03-02

Locations

15 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT03801928. Inclusion in this directory is not an endorsement.