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

Last updated on November 14, 2019

FOR MORE INFORMATION
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.
Show details

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.
Show details

-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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Descriptive Information
Brief TitleObservational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
Official TitleOBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA
Brief SummaryThis 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-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:

  • 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.
Condition
  • Inflammatory Bowel Disease (IBD)
  • Crohn's Disease (CD)
  • Ulcerative Colitis (UC)
InterventionDrug: 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
  • 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
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 StatusRecruiting
Estimated Enrollment
 (submitted: January 9, 2019)
300
Original Estimated EnrollmentSame as current
Estimated Study Completion DateJune 30, 2020
Estimated Primary Completion DateJune 30, 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:

  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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03801928
Other Study ID NumbersC1231006
ONWARD ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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