Clinical trial NCT03801928: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease (IBD)
Crohn's Disease (CD)
Ulcerative Colitis (UC)
Keywords: Inflectra
Remicade
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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:

* 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.

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.


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.

Primary outcomes:
measure: Average Dose of Inflectra at Visit 1
timeFrame: Visit 1= Day 1
measure: Average Dose of Inflectra at Visit 2
timeFrame: Visit 2= Day 90
measure: Average Dose of Inflectra at Visit 3
timeFrame: Visit 3= Day 180
measure: Average Dose of Inflectra at Visit 4
timeFrame: Visit 4= Day 365
measure: Mean Number of Inflectra Infusions at Visit 1
timeFrame: Visit 1= Day 1
measure: Mean Number of Inflectra Infusions at Visit 2
timeFrame: Visit 2= Day 90
measure: Mean Number of Inflectra Infusions at Visit 3
timeFrame: Visit 3= Day 180
measure: Mean Number of Inflectra Infusions at Visit 4
timeFrame: Visit 4= Day 365
Secondary outcomes:
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4
timeFrame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis
timeFrame: Baseline (before initiation of Inflectra)
measure: Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease
timeFrame: Baseline (before initiation of Inflectra)
measure: Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis
timeFrame: Baseline (before initiation of Inflectra)
measure: Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease
timeFrame: Baseline (before initiation of Inflectra)
measure: Number of Participants With Infections
timeFrame: Visit 1 to 4 (approximately 1 year)
measure: Number of Participants With Malignancy and Lymphoma
timeFrame: Visit 1 to 4 (approximately 1 year)
measure: Number of Participants With Infusion-related Reactions
timeFrame: Visit 1 to 4 (approximately 1 year)
measure: Number of Participants With Any Serious Adverse Event
timeFrame: Visit 1 to 4 (approximately 1 year)
Other outcomes:
measure: Duration of Inflectra Therapy
timeFrame: Visit 1 to 4 (approximately 1 year)
measure: Number of Participants With Any Changes in Dosing
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
measure: Number of Participants Who Completed Each Study Visit
timeFrame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Locations:
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Hamden
country: United States
facility: Medical Research Center Of Connecticut, LLC
state: Connecticut
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Gurnee
country: United States
facility: Illinois Gastroenterology Group
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Division of Gastroenterology/Hepatology
state: Indiana
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Grand Rapids
country: United States
facility: Infusion Associates N.E.
state: Michigan
city: Minot
country: United States
facility: Trinity Health Center Medical Arts
state: North Dakota
city: Beavercreek
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & consulting, LLC
state: Ohio
city: Vancouver
country: United States
facility: The Vancouver Clinic Research
state: Washington
city: Calgary
country: Canada
facility: Aspen Woods Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Brennan Walters Professional Corporation
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials
state: British Columbia
city: Montreal
country: Canada
facility: Montreal IBD Center (CMIIM)
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.