Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/16/2019 |
| Start Date: | February 23, 2018 |
| End Date: | June 30, 2020 |
| Contact: | Pfizer CT.gov Call Center |
| Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
| Phone: | 1-800-718-1021 |
OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
