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Clinical Trials/NCT03801928
NCT03801928CompletedNot Applicable

OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA

Pfizer15 sites in 2 countries118 target enrollmentStarted: February 23, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Pfizer
Enrollment
118
Locations
15
Primary Endpoint
Mean Number of Inflectra Infusions at Visit 1
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients must meet all of the following criteria to be eligible for inclusion in the study:
  • •Patients with confirmed diagnosis of Ulcerative Colitis or Crohn's Disease.
  • •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  • •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:
  • •Patient previously failed treatment with REMICADE or INFLECTRA/CT P
  • •Any reported contraindications for INFLECTRA/CT P13 or REMICADE.
  • •Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.

Arms & Interventions

Ulcerative Colitis

Group treated with Inflectra for Ulcerative Colitis

Intervention: Inflectra (Drug)

Crohn's Disease

Group treated with Inflectra for Crohn's Disease

Intervention: Inflectra (Drug)

Outcomes

Primary Outcomes

Mean Number of Inflectra Infusions at Visit 1

Time Frame: Visit 1= Day 1

Average Dose of Inflectra at Visit 1

Time Frame: Visit 1= Day 1

Average Dose of Inflectra at Visit 2

Time Frame: Visit 2= Day 90

Average Dose of Inflectra at Visit 3

Time Frame: Visit 3= Day 180

Average Dose of Inflectra at Visit 4

Time Frame: Visit 4= Day 365

Mean Number of Inflectra Infusions at Visit 2

Time Frame: Visit 2= Day 90

Mean Number of Inflectra Infusions at Visit 3

Time Frame: Visit 3= Day 180

Mean Number of Inflectra Infusions at Visit 4

Time Frame: Visit 4= Day 365

Secondary Outcomes

  • Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4(Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4(Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365)
  • Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis(Baseline (before initiation of Inflectra))
  • Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease(Baseline (before initiation of Inflectra))
  • Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis(Baseline (before initiation of Inflectra))
  • Number of Participants With Infections(Visit 1 to 4 (approximately 1 year))
  • Number of Participants With Malignancy and Lymphoma(Visit 1 to 4 (approximately 1 year))
  • Number of Participants With Any Serious Adverse Event(Visit 1 to 4 (approximately 1 year))
  • Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease(Baseline (before initiation of Inflectra))
  • Number of Participants With Infusion-related Reactions(Visit 1 to 4 (approximately 1 year))

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (15)

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