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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801928
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease (IBD) Crohn's Disease (CD) Ulcerative Colitis (UC) Drug: Inflectra

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA
Actual Study Start Date : February 23, 2018
Actual Primary Completion Date : February 7, 2020
Actual Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
Ulcerative Colitis
Group treated with Inflectra for Ulcerative Colitis
Drug: 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

Crohn's Disease
Group treated with Inflectra for Crohn's Disease
Drug: 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




Primary Outcome Measures :
  1. Duration of Remicade and/or Inflectra therapy and time between lines of therapy [ Time Frame: From Baseline through 12 months ]
  2. Proportion of patients who change dosing and/or dosing schedule [ Time Frame: From Baseline thtough 12 months ]
  3. Proportion of patients who discontinue treatment and the rationale [ Time Frame: From Baseline through 12 months ]
  4. Proportion of patients adhering to treatment regimen [ Time Frame: From Baseline through 12 months ]
  5. Number of health care related visits for all indications [ Time Frame: From Baseline through 12 months ]

Secondary Outcome Measures :
  1. Crohn's disease response and remission based on Harvey Bradshaw Index score [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    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.

  2. Ulcerative colitis response and remission based on Partial Mayo score [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    Ulcerative colitis remission indicated by partial Mayo score <3 points. Ulcerative colitis response if reduction of partial Mayo score of ≥3 points from baseline.

  3. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) for Chron's disease and ulcerative colitis [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    All indications - Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score. Score ranges from 10-70, with higher scores being better.

  4. Quality of Life Visual Analog Scale (VAS) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    All indications - Change in Quality of Life Visual Analog Scale (VAS), from baseline. VAS ranges from 0-100, with higher scores being better.

  5. Score on Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    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).

  6. Count of health care related resource utilizations at each study visit [ Time Frame: From Baseline through 12 months ]
    For all indications - Count of health care related visits at each time point, including hospitalizations, Emergency Department visits, office visits and infusion clinic visits

  7. Work Productivity and Activity Impairment (WPAI) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    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 productivity while working. Scores are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801928


Locations
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United States, California
San Diego Clinical Trials
San Diego, California, United States, 92120
United States, Connecticut
Medical Research Center Of Connecticut, LLC
Hamden, Connecticut, United States, 06518
United States, Florida
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
United States, Illinois
Illinois Gastroenterology Group
Gurnee, Illinois, United States, 60031
United States, Indiana
Indiana University Health Division of Gastroenterology/Hepatology
Indianapolis, Indiana, United States, 46202
United States, Maryland
Gastro Center of Maryland
Columbia, Maryland, United States, 21045
United States, Michigan
Infusion Associates N.E.
Grand Rapids, Michigan, United States, 49525
United States, North Dakota
Trinity Health Center Medical Arts
Minot, North Dakota, United States, 58701
United States, Ohio
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States, 45440
Paramount Medical Research & consulting, LLC
Middleburg Heights, Ohio, United States, 44130
United States, Washington
The Vancouver Clinic Research
Vancouver, Washington, United States, 98664
Canada, Alberta
Aspen Woods Clinic
Calgary, Alberta, Canada, T3H 0V5
Brennan Walters Professional Corporation
Edmonton, Alberta, Canada, T5R 1W2
Canada, British Columbia
Fraser Clinical Trials
New Westminster, British Columbia, Canada, V3L 3W5
Canada, Quebec
Montreal IBD Center (CMIIM)
Montreal, Quebec, Canada, H2V 2X1
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03801928    
Other Study ID Numbers: C1231006
ONWARD ( Other Identifier: Alias Study Number )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (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/data_requests.
Keywords provided by Pfizer:
Inflectra
Remicade
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents