Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
NCT03801928
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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).
-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.
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Descriptive Information | |||||
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Brief Title | Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease | ||||
Official Title | OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | 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:
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Condition |
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Intervention | Drug: 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 Name: Infliximab | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 118 | ||||
Original Estimated Enrollment | 300 | ||||
Actual Study Completion Date | February 7, 2020 | ||||
Actual Primary Completion Date | February 7, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: Patients must meet all of the following criteria to be eligible for inclusion in the study:
Exclusion Criteria: -Patients meeting any of the following criteria will not be included in the study:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03801928 | ||||
Other Study ID Numbers | C1231006 ONWARD ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | February 2021 |