Columbia, Maryland 21045


Purpose:

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.


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.


Study is Available At:


Original ID:

C1231006


NCT ID:

NCT03801928


Secondary ID:

ONWARD


Study Acronym:

ONWARD


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer
Primary Contact:Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Study Dates

Start Date:February 23, 2018
Completion Date:June 30, 2020
Completion Type:Anticipated
Primary Completion Date:June 30, 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 9, 2019
First Received Date:December 11, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Work Productivity and Activity Impairment (WPAI)
Time Frame:Baseline, 3 months, 6 months, 12 months
Safety Issues:False
Description:All indications - Work Performance and Activity Impairment (WPAI) has 6 questions, related to the preceding 7 days. The questions consider hours missed from work due to health, hours missed because of other reasons (e.g., holidays), hours worked and produ
Outcome Type:Secondary Outcome
Measure:Count of health care related resource utilizations at each study visit
Time Frame:From Baseline through 12 months
Safety Issues:False
Description:For all indications - Count of health care related visits at each time point, including hospitalizations, Emergency Department visits, office visits and infusion clinic visits
Outcome Type:Secondary Outcome
Measure:Score on Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame:Baseline, 3 months, 6 months, 12 months
Safety Issues:False
Description:All indications - Treatment Satisfaction Questionnaire for Medication (TSQM) is a generic instrument with a total score and four domain scores: side effects (5 items), effectiveness (3 items), convenience (3 items), and global satisfaction (3 items).
Outcome Type:Secondary Outcome
Measure:Quality of Life Visual Analog Scale (VAS)
Time Frame:Baseline, 3 months, 6 months, 12 months
Safety Issues:False
Description:All indications - Change in Quality of Life Visual Analog Scale (VAS), from baseline. VAS ranges from 0-100, with higher scores being better.
Outcome Type:Secondary Outcome
Measure:Short Inflammatory Bowel Disease Questionnaire (SIBDQ) for Chron's disease and ulcerative colitis
Time Frame:Baseline, 3 months, 6 months, 12 months
Safety Issues:False
Description:All indications - Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score. Score ranges from 10-70, with higher scores being better.
Outcome Type:Secondary Outcome
Measure:Ulcerative colitis response and remission based on Partial Mayo score
Time Frame:Baseline, 3 months, 6 months, 12 months
Safety Issues:False
Description:Ulcerative colitis remission indicated by partial Mayo score <3 points. Ulcerative colitis response if reduction of partial Mayo score of ≥3 points from baseline.
Outcome Type:Secondary Outcome
Measure:Crohn's disease response and remission based on Harvey Bradshaw Index score
Time Frame:Baseline, 3 months, 6 months, 12 months
Safety Issues:False
Description:Crohn's disease remission indicated by Harvey Bradshaw Index score <5. Crohn's disease response if reduction of Harvey Bradshaw Score of ≥3 points from baseline.
Outcome Type:Primary Outcome
Measure:Number of health care related visits for all indications
Time Frame:From Baseline through 12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Proportion of patients adhering to treatment regimen
Time Frame:From Baseline through 12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Proportion of patients who discontinue treatment and the rationale
Time Frame:From Baseline through 12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Proportion of patients who change dosing and/or dosing schedule
Time Frame:From Baseline through 12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Duration of Remicade and/or Inflectra therapy and time between lines of therapy
Time Frame:From Baseline through 12 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Inflectra
Description: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.
Arm Name:Ulcerative Colitis
Other Name:Infliximab

Study Arms

Study Arm Type:Other
Arm Name:Crohn's Disease
Description:Group treated with Inflectra for Crohn's Disease
Study Arm Type:Other
Arm Name:Ulcerative Colitis
Description:Group treated with Inflectra for Ulcerative Colitis

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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