Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Disease (IBD)Crohn's Disease (CD)Ulcerative Colitis (UC)
- Interventions
- Registration Number
- NCT03801928
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
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).
-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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ulcerative Colitis Inflectra Group treated with Inflectra for Ulcerative Colitis Crohn's Disease Inflectra Group treated with Inflectra for Crohn's Disease
- Primary Outcome Measures
Name Time Method Mean Number of Inflectra Infusions at Visit 1 Visit 1= Day 1 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 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 Outcome Measures
Name Time Method 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 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.
Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
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 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.
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 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.
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 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.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
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 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.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.
Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 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.
Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis Baseline (before initiation of Inflectra) Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease Baseline (before initiation of Inflectra) 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 \[GI\]).
Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis Baseline (before initiation of Inflectra) 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.
Number of Participants With Infections Visit 1 to 4 (approximately 1 year) 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.
Number of Participants With Malignancy and Lymphoma Visit 1 to 4 (approximately 1 year) 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.
Number of Participants With Any Serious Adverse Event Visit 1 to 4 (approximately 1 year) 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.
Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease Baseline (before initiation of Inflectra) 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.
Number of Participants With Infusion-related Reactions Visit 1 to 4 (approximately 1 year) 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.
Trial Locations
- Locations (15)
San Diego Clinical Trials
🇺🇸San Diego, California, United States
Medical Research Center Of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Montreal IBD Center (CMIIM)
🇨🇦Montreal, Quebec, Canada
The Vancouver Clinic Research
🇺🇸Vancouver, Washington, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Gastro Center of Maryland
🇺🇸Columbia, Maryland, United States
Trinity Health Center Medical Arts
🇺🇸Minot, North Dakota, United States
Paramount Medical Research & consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
Indiana University Health Division of Gastroenterology/Hepatology
🇺🇸Indianapolis, Indiana, United States
Brennan Walters Professional Corporation
🇨🇦Edmonton, Alberta, Canada
Fraser Clinical Trials
🇨🇦New Westminster, British Columbia, Canada
Infusion Associates N.E.
🇺🇸Grand Rapids, Michigan, United States
Dayton Gastroenterology, Inc.
🇺🇸Beavercreek, Ohio, United States
Aspen Woods Clinic
🇨🇦Calgary, Alberta, Canada
Illinois Gastroenterology Group
🇺🇸Gurnee, Illinois, United States