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

Pfizer

Status

Completed

Conditions

Inflammatory Bowel Disease (IBD)

Ulcerative Colitis (UC)

Crohn's Disease (CD)

Treatments

Drug: Inflectra

Study type

Observational

Funder types

Industry

Identifiers

NCT03801928

ONWARD (Other Identifier)

C1231006

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

-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.