NCT03801928

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 2, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

December 11, 2018

Results QC Date

February 8, 2021

Last Update Submit

February 8, 2021

Conditions

Inflammatory Bowel Disease (IBD)Crohn's Disease (CD)Ulcerative Colitis (UC)

Keywords

InflectraRemicade

Outcome Measures

Primary Outcomes (8)

  • Average Dose of Inflectra at Visit 1

    Visit 1= Day 1

  • Average Dose of Inflectra at Visit 2

    Visit 2= Day 90

  • Average Dose of Inflectra at Visit 3

    Visit 3= Day 180

  • Average Dose of Inflectra at Visit 4

    Visit 4= Day 365

  • Mean Number of Inflectra Infusions at Visit 1

    Visit 1= Day 1

  • Mean Number of Inflectra Infusions at Visit 2

    Visit 2= Day 90

  • Mean Number of Inflectra Infusions at Visit 3

    Visit 3= Day 180

  • Mean Number of Inflectra Infusions at Visit 4

    Visit 4= Day 365

Secondary Outcomes (26)

  • 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 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 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

  • +21 more secondary outcomes

Other Outcomes (3)

  • Duration of Inflectra Therapy

    Visit 1 to 4 (approximately 1 year)

  • Number of Participants With Any Changes in Dosing

    Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

  • Number of Participants Who Completed Each Study Visit

    Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365

Study Arms (2)

Ulcerative Colitis

Group treated with Inflectra for Ulcerative Colitis

Drug: Inflectra

Crohn's Disease

Group treated with Inflectra for Crohn's Disease

Drug: Inflectra

Interventions

InflectraDRUG

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.

Also known as: Infliximab
Crohn's DiseaseUlcerative Colitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

You may qualify if:

  • 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).

You may not qualify if:

  • Patients meeting any of the following criteria will not be included in the study:
  • Patient previously failed treatment with REMICADE or INFLECTRA/CT P13.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

San Diego Clinical Trials

San Diego, California, 92120, United States

Location

Medical Research Center Of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

Illinois Gastroenterology Group

Gurnee, Illinois, 60031, United States

Location

Indiana University Health Division of Gastroenterology/Hepatology

Indianapolis, Indiana, 46202, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Infusion Associates N.E.

Grand Rapids, Michigan, 49525, United States

Location

Trinity Health Center Medical Arts

Minot, North Dakota, 58701, United States

Location

Dayton Gastroenterology, Inc.

Beavercreek, Ohio, 45440, United States

Location

Paramount Medical Research & consulting, LLC

Middleburg Heights, Ohio, 44130, United States

Location

The Vancouver Clinic Research

Vancouver, Washington, 98664, United States

Location

Aspen Woods Clinic

Calgary, Alberta, T3H 0V5, Canada

Location

Brennan Walters Professional Corporation

Edmonton, Alberta, T5R 1W2, Canada

Location

Fraser Clinical Trials

New Westminster, British Columbia, V3L 3W5, Canada

Location

Montreal IBD Center (CMIIM)

Montreal, Quebec, H2V 2X1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35296993DERIVED

Related Links

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

January 14, 2019

Study Start

February 23, 2018

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

March 2, 2021

Results First Posted

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

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/data\_requests.

Locations

CA(4)US(11)