- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801928
Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease (ONWARD)
OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T3H 0V5
- Aspen Woods Clinic
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Edmonton, Alberta, Canada, T5R 1W2
- Brennan Walters Professional Corporation
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W5
- Fraser Clinical Trials
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Quebec
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Montreal, Quebec, Canada, H2V 2X1
- Montreal IBD Center (CMIIM)
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California
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San Diego, California, United States, 92120
- San Diego Clinical Trials
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Connecticut
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Hamden, Connecticut, United States, 06518
- Medical Research Center of Connecticut, LLC
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Florida
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Miami, Florida, United States, 33135
- Suncoast Research Group, LLC
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Illinois
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Gurnee, Illinois, United States, 60031
- Illinois Gastroenterology Group
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Health Division of Gastroenterology/Hepatology
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Maryland
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Columbia, Maryland, United States, 21045
- Gastro Center of Maryland
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Michigan
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Grand Rapids, Michigan, United States, 49525
- Infusion Associates N.E.
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North Dakota
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Minot, North Dakota, United States, 58701
- Trinity Health Center Medical Arts
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Ohio
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Beavercreek, Ohio, United States, 45440
- Dayton Gastroenterology, Inc.
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Middleburg Heights, Ohio, United States, 44130
- Paramount Medical Research & Consulting, LLC
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Washington
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Vancouver, Washington, United States, 98664
- The Vancouver Clinic Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Ulcerative Colitis
Group treated with Inflectra for Ulcerative Colitis
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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 Names:
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Crohn's Disease
Group treated with Inflectra for Crohn's Disease
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average Dose of Inflectra at Visit 1
Time Frame: Visit 1= Day 1
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Visit 1= Day 1
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Average Dose of Inflectra at Visit 2
Time Frame: Visit 2= Day 90
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Visit 2= Day 90
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Average Dose of Inflectra at Visit 3
Time Frame: Visit 3= Day 180
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Visit 3= Day 180
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Average Dose of Inflectra at Visit 4
Time Frame: Visit 4= Day 365
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Visit 4= Day 365
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Mean Number of Inflectra Infusions at Visit 1
Time Frame: Visit 1= Day 1
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Visit 1= Day 1
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Mean Number of Inflectra Infusions at Visit 2
Time Frame: Visit 2= Day 90
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Visit 2= Day 90
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Mean Number of Inflectra Infusions at Visit 3
Time Frame: Visit 3= Day 180
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Visit 3= Day 180
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Mean Number of Inflectra Infusions at Visit 4
Time Frame: Visit 4= Day 365
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Visit 4= Day 365
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work.
The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment.
All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work.
The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment.
All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work.
The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment.
All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work.
The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment.
All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects.
Convenience score utilized items 7 and 8. Items 7 and 8 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied.
Convenience score was calculated using formula = ([Sum of Item 7 + Item 8] - 2)/12*100.
Convenience score ranged from 0 (no convenience) to 100 (best level of convenience).
Higher convenience scores indicated more convenience with medication and greater satisfaction.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects.
Effectiveness score utilized items 1 and 2. Items 1 and 2 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied.
Effectiveness score was calculated using formula= ([Sum of Item 1 + Item 2] - 2)/12*100.
Effectiveness score ranged from 0 (not effective) to 100 (highest level of effectiveness).
Higher effectiveness scores indicated medication was more effective and greater satisfaction.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects.
Side effects score utilized items 4, 5 and 6.
Items 4, 5 and 6 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied.
Side effects score was calculated using formula = ([Sum of Item 4 + Item 5 + Item 6] - 3)/12*100, if one item is missing then: ([Sum of two completed items from 4 to 6] - 2]/8*100.
Side effects score ranged from 0 (maximum side effects) to 100 (no side effects).
Higher side effects scores indicated less side effects with medication and greater satisfaction.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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In this outcome measure mean of total number of ED visits at specified time points as a part of healthcare resource utilization assessment are reported.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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In this outcome measure mean of total number of outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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In this outcome measure mean of total number of gastroenterology outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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In this outcome measure mean of total number of general practitioner outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Participants with a confirmed diagnosis of CD, were said to have remission when Harvey-Bradshaw index (HBI) score was less than (<) 5. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess).
The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools.
Higher HBI scores = greater disease activity.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Participants with a confirmed diagnosis of UC, were said to have remission when there was a reduction of partial Mayo score (PMS) of <3 points from baseline.
PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease).
The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease).
Higher scores indicated more severe disease.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Participants with a confirmed diagnosis of CD, were said to have response when there was reduction of HBI score of >=3 points from baseline.
HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess).
The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools.
Higher HBI scores = greater disease activity.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Participants with a confirmed diagnosis of UC, were said to have response when there was a reduction of partial Mayo score of >=3 points from baseline.
PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease).
The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease).
Higher scores indicated more severe disease.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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This questionnaire is designed to find out how participants felt during the last 2 weeks.
Participants were asked 10 questions about physical, social, and emotional status.
Participants had to respond for every question on a scale from 1 (poor) to 7 (good).
Total SIBDQ score was sum of scores from 10 questions, with range from 10 (poor quality of life) to 70 (optimum quality of life), higher values indicated better well-being.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4
Time Frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Participants were asked to mark their overall well-being at specified visits on a scale from 0 millimeter to 100 millimeter.
0 indicated worst health and 100 indicated perfect health.
Higher scores indicated better well-being.
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Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis
Time Frame: Baseline (before initiation of Inflectra)
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Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).
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Baseline (before initiation of Inflectra)
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Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease
Time Frame: Baseline (before initiation of Inflectra)
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Participants with Montreal classification for CD was reported for behavior (B1: nonstricturing, no penetrating, B2: structuring, B3: penetrating, P: perianal disease, unknown) and location (L1: terminal ileum, L2: colon, L3: ileocolon, L4: upper gastrointestinal [GI]).
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Baseline (before initiation of Inflectra)
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Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis
Time Frame: Baseline (before initiation of Inflectra)
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PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease).
The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease).
Higher scores indicated more severe disease.
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Baseline (before initiation of Inflectra)
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Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease
Time Frame: Baseline (before initiation of Inflectra)
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HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess).
The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends depended on the number of liquids stools.
Higher HBI scores = greater disease activity.
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Baseline (before initiation of Inflectra)
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Number of Participants With Infections
Time Frame: Visit 1 to 4 (approximately 1 year)
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In this outcome measure, number of participants who had infections as adverse events are reported under 2 categories: 1) all infections (including both serious and non-serious adverse events) and 2) serious infections (serious adverse event).
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
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Visit 1 to 4 (approximately 1 year)
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Number of Participants With Malignancy and Lymphoma
Time Frame: Visit 1 to 4 (approximately 1 year)
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In this outcome measure, number of participants who had malignancy and lymphoma as adverse events are reported under 2 categories: 1) malignancy and lymphoma (serious adverse event) and 2) malignancy and lymphoma (non-serious adverse event.
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
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Visit 1 to 4 (approximately 1 year)
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Number of Participants With Infusion-related Reactions
Time Frame: Visit 1 to 4 (approximately 1 year)
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In this outcome measure, number of participants who had infusion-related reactions as adverse events are reported under 2 categories: 1) infusion-related reactions (serious adverse event) and 2) infusion-related reactions (non-serious adverse event) are reported.
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
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Visit 1 to 4 (approximately 1 year)
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Number of Participants With Any Serious Adverse Event
Time Frame: Visit 1 to 4 (approximately 1 year)
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An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
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Visit 1 to 4 (approximately 1 year)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Inflectra Therapy
Time Frame: Visit 1 to 4 (approximately 1 year)
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In this outcome measure duration of Inflectra treatment (in months) is reported.
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Visit 1 to 4 (approximately 1 year)
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Number of Participants With Any Changes in Dosing
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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In this outcome measure, number of participants who had any changes in dosing are reported.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Number of Participants Who Completed Each Study Visit
Time Frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence.
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Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1231006
- ONWARD (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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