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

A total of 300 patients are planned to be enrolled from approximately 30 40 physician clinics. Enrollment is planned to be competitive, but an upper limit of 20 patients per site per cohort will be applied to maintain the generalizability of the study. This is an observational study; therefore the decision to treat a patient with INFLECTRA must be made prior to a decision to enroll them in this study. Patients are eligible to participate if they have:

• Initiated therapy with INFLECTRA as their first biologic;
• Switched to INFLECTRA while in remission on a stable dose of REMICADE; or,
• Switched to INFLECTRA from another biologic, due to non responsiveness, intolerance, or other reasons.

• Inflammatory Bowel Disease (IBD)
• Crohn's Disease (CD)
• Ulcerative Colitis (UC)

• Ulcerative Colitis
  Group treated with Inflectra for Ulcerative Colitis
  Intervention: Drug: Inflectra
• Crohn's Disease
  Group treated with Inflectra for Crohn's Disease
  Intervention: Drug: 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.