Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
NCT ID: NCT03801928
Last Updated: 2021-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
118 participants
OBSERVATIONAL
2018-02-23
2020-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ulcerative Colitis
Group treated with Inflectra for Ulcerative Colitis
Inflectra
The 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.
Crohn's Disease
Group treated with Inflectra for Crohn's Disease
Inflectra
The 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.
Interventions
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Inflectra
The 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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San Diego Clinical Trials
San Diego, California, United States
Medical Research Center Of Connecticut, LLC
Hamden, Connecticut, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Illinois Gastroenterology Group
Gurnee, Illinois, United States
Indiana University Health Division of Gastroenterology/Hepatology
Indianapolis, Indiana, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Infusion Associates N.E.
Grand Rapids, Michigan, United States
Trinity Health Center Medical Arts
Minot, North Dakota, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States
Paramount Medical Research & consulting, LLC
Middleburg Heights, Ohio, United States
The Vancouver Clinic Research
Vancouver, Washington, United States
Aspen Woods Clinic
Calgary, Alberta, Canada
Brennan Walters Professional Corporation
Edmonton, Alberta, Canada
Fraser Clinical Trials
New Westminster, British Columbia, Canada
Montreal IBD Center (CMIIM)
Montreal, Quebec, Canada
Countries
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References
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Abraham B, Eksteen B, Nedd K, Kale H, Patel D, Stephens J, Shelbaya A, Chambers R, Soonasra A. Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study). Adv Ther. 2022 May;39(5):2109-2127. doi: 10.1007/s12325-022-02104-6. Epub 2022 Mar 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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ONWARD
Identifier Type: OTHER
Identifier Source: secondary_id
C1231006
Identifier Type: -
Identifier Source: org_study_id
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