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

Last updated on February 17, 2019

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Study Location
Gastro Center of Maryland
Columbia, Maryland, 21045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammatory Bowel Disease (IBD), Crohn's Disease (CD), Ulcerative Colitis (UC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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-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.

NCT03801928
Pfizer
Recruiting
Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease

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[email protected]

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