Crohn's Disease (CD), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
Inflectra, Remicade
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.
Interventions
DRUGInflectra
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.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Number of Inflectra Infusions 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
| 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. |
| 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. |
| 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 \[GI\]). |
| 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). |
| 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. |
| 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 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 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. |
| 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. |
| 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 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 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 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Inflectra Therapy | Visit 1 to 4 (approximately 1 year) | In this outcome measure duration of Inflectra treatment (in months) is reported. |
| Number of Participants Who Completed Each Study Visit | Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 | In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence. |
| Number of Participants With Any Changes in Dosing | Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 | In this outcome measure, number of participants who had any changes in dosing are reported. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants included had inflammatory bowel disease (IBD), with a confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD): 1) those who newly initiated therapy with Inflectra as their first biologic, 2) transitioned to Inflectra from Remicade, 3) switched to Inflectra from other biologics. Total 118 participants were enrolled and assessed for eligibility. Out of 118, only 115 participants received Inflectra and were eligible to be included in the study.
Pre-assignment details
Participants initiated or switched to Inflectra in a real-world setting and it was a decision made by physician irrespective of this study. Inflectra dose was per summary of product characteristics as determined by physician, for every 8 weeks. Participants were observed and evaluated prospectively at 4 study visits (visit 1= Day 1, visit 2= Day 90, visit 3= Day 180, visit 4= Day 365; all visits were from first dose of Inflectra) for approximately (approx.) 1 year after treatment with Inflectra.
Participants by arm
| Arm | Count |
|---|---|
| UC: New Inflectra Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic. | 18 |
| UC: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade. | 21 |
| UC: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics. | 9 |
| CD: New Inflectra Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic. | 21 |
| CD: Inflectra After Remicade Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade. | 36 |
| CD: Inflectra After Other Biologics Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics. | 10 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 2 | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 1 | 1 | 4 | 4 | 2 |
| Overall Study | Other | 0 | 2 | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | UC: New Inflectra | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.76 Years STANDARD_DEVIATION 12.68 | 51.67 Years STANDARD_DEVIATION 16.39 | 44.94 Years STANDARD_DEVIATION 17.72 | 46.86 Years STANDARD_DEVIATION 17.98 | 43.40 Years STANDARD_DEVIATION 17.02 | 39.00 Years STANDARD_DEVIATION 14.51 | 44.25 Years STANDARD_DEVIATION 16.29 |
| Concomitant Medication Usage | 14 Participants | 7 Participants | 18 Participants | 18 Participants | 16 Participants | 9 Participants | 82 Participants |
| Disease Duration | 8.88 Years STANDARD_DEVIATION 8.86 | 10.00 Years STANDARD_DEVIATION 9.11 | 5.96 Years STANDARD_DEVIATION 6.4 | 5.89 Years STANDARD_DEVIATION 6.3 | 10.59 Years STANDARD_DEVIATION 10.28 | 7.22 Years STANDARD_DEVIATION 7.45 | 8.26 Years STANDARD_DEVIATION 8.47 |
| Insurance Plan Coverage Canada Medicare | 0 Participants | 4 Participants | 4 Participants | 4 Participants | 0 Participants | 4 Participants | 16 Participants |
| Insurance Plan Coverage Health Maintenance Organization (HMO) | 18 Participants | 0 Participants | 2 Participants | 2 Participants | 22 Participants | 2 Participants | 46 Participants |
| Insurance Plan Coverage Medicare/Medicaid | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 9 Participants | 1 Participants | 25 Participants |
| Insurance Plan Coverage Point of Service Plan (POS) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Insurance Plan Coverage Preferred Provider Organization (PPO) | 0 Participants | 2 Participants | 9 Participants | 9 Participants | 4 Participants | 2 Participants | 26 Participants |
| Insurance Plan Coverage Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Medication History | 21 Participants | 9 Participants | 0 Participants | 1 Participants | 36 Participants | 9 Participants | 76 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized White or Caucasian American | 20 Participants | 6 Participants | 16 Participants | 18 Participants | 31 Participants | 9 Participants | 100 Participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 8 Participants | 8 Participants | 19 Participants | 6 Participants | 59 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 10 Participants | 13 Participants | 17 Participants | 4 Participants | 56 Participants |
| Surgical History | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 15 Participants | 3 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 21 | 0 / 9 | 0 / 21 | 0 / 36 | 0 / 10 |
| other Total, other adverse events | 2 / 18 | 4 / 21 | 5 / 9 | 6 / 21 | 7 / 36 | 3 / 10 |
| serious Total, serious adverse events | 0 / 18 | 3 / 21 | 1 / 9 | 5 / 21 | 8 / 36 | 2 / 10 |
Outcome results
Primary
Average Dose of Inflectra at Visit 1
Time frame: Visit 1= Day 1
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Average Dose of Inflectra at Visit 1 | 457.28 milligram | Standard Deviation 184.03 |
| UC: Inflectra After Remicade | Average Dose of Inflectra at Visit 1 | 585.71 milligram | Standard Deviation 305.43 |
| UC: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 1 | 579.44 milligram | Standard Deviation 193.69 |
| CD: New Inflectra | Average Dose of Inflectra at Visit 1 | 449.76 milligram | Standard Deviation 102.33 |
| CD: Inflectra After Remicade | Average Dose of Inflectra at Visit 1 | 521.83 milligram | Standard Deviation 274.76 |
| CD: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 1 | 534.90 milligram | Standard Deviation 171.15 |
Primary
Average Dose of Inflectra at Visit 2
Time frame: Visit 2= Day 90
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Average Dose of Inflectra at Visit 2 | 491.66 milligram | Standard Deviation 201.43 |
| UC: Inflectra After Remicade | Average Dose of Inflectra at Visit 2 | 535.29 milligram | Standard Deviation 259.67 |
| UC: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 2 | 662.36 milligram | Standard Deviation 194.54 |
| CD: New Inflectra | Average Dose of Inflectra at Visit 2 | 491.62 milligram | Standard Deviation 172.95 |
| CD: Inflectra After Remicade | Average Dose of Inflectra at Visit 2 | 506.97 milligram | Standard Deviation 236.03 |
| CD: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 2 | 575.00 milligram | Standard Deviation 210.76 |
Primary
Average Dose of Inflectra at Visit 3
Time frame: Visit 3= Day 180
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Average Dose of Inflectra at Visit 3 | 556.34 milligram | Standard Deviation 216.05 |
| UC: Inflectra After Remicade | Average Dose of Inflectra at Visit 3 | 531.25 milligram | Standard Deviation 270.11 |
| UC: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 3 | 647.67 milligram | Standard Deviation 328.73 |
| CD: New Inflectra | Average Dose of Inflectra at Visit 3 | 517.87 milligram | Standard Deviation 162.06 |
| CD: Inflectra After Remicade | Average Dose of Inflectra at Visit 3 | 544.40 milligram | Standard Deviation 233.21 |
| CD: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 3 | 621.00 milligram | Standard Deviation 230.55 |
Primary
Average Dose of Inflectra at Visit 4
Time frame: Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Average Dose of Inflectra at Visit 4 | 409.28 milligram | Standard Deviation 216.59 |
| UC: Inflectra After Remicade | Average Dose of Inflectra at Visit 4 | 552.00 milligram | Standard Deviation 270.43 |
| UC: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 4 | 450.00 milligram | Standard Deviation 70.71 |
| CD: New Inflectra | Average Dose of Inflectra at Visit 4 | 536.12 milligram | Standard Deviation 216.39 |
| CD: Inflectra After Remicade | Average Dose of Inflectra at Visit 4 | 553.20 milligram | Standard Deviation 238.22 |
| CD: Inflectra After Other Biologics | Average Dose of Inflectra at Visit 4 | 610.15 milligram | Standard Deviation 229.08 |
Primary
Mean Number of Inflectra Infusions at Visit 1
Time frame: Visit 1= Day 1
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Mean Number of Inflectra Infusions at Visit 1 | 1.56 infusions | Standard Deviation 0.62 |
| UC: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 1 | 1.00 infusions | Standard Deviation 0 |
| UC: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 1 | 1.44 infusions | Standard Deviation 0.53 |
| CD: New Inflectra | Mean Number of Inflectra Infusions at Visit 1 | 1.43 infusions | Standard Deviation 0.51 |
| CD: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 1 | 1.11 infusions | Standard Deviation 0.32 |
| CD: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 1 | 1.70 infusions | Standard Deviation 0.67 |
Primary
Mean Number of Inflectra Infusions at Visit 2
Time frame: Visit 2= Day 90
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Mean Number of Inflectra Infusions at Visit 2 | 2.06 infusions | Standard Deviation 0.75 |
| UC: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 2 | 1.76 infusions | Standard Deviation 0.44 |
| UC: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 2 | 2.38 infusions | Standard Deviation 1.06 |
| CD: New Inflectra | Mean Number of Inflectra Infusions at Visit 2 | 1.95 infusions | Standard Deviation 0.83 |
| CD: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 2 | 1.47 infusions | Standard Deviation 0.51 |
| CD: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 2 | 2.00 infusions | Standard Deviation 0.53 |
Primary
Mean Number of Inflectra Infusions at Visit 3
Time frame: Visit 3= Day 180
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Mean Number of Inflectra Infusions at Visit 3 | 1.56 infusions | Standard Deviation 0.63 |
| UC: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 3 | 1.38 infusions | Standard Deviation 0.62 |
| UC: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 3 | 2.20 infusions | Standard Deviation 1.3 |
| CD: New Inflectra | Mean Number of Inflectra Infusions at Visit 3 | 1.47 infusions | Standard Deviation 0.83 |
| CD: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 3 | 1.40 infusions | Standard Deviation 0.5 |
| CD: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 3 | 1.40 infusions | Standard Deviation 0.55 |
Primary
Mean Number of Inflectra Infusions at Visit 4
Time frame: Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Mean Number of Inflectra Infusions at Visit 4 | 2.56 infusions | Standard Deviation 0.88 |
| UC: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 4 | 3.00 infusions | Standard Deviation 0.85 |
| UC: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 4 | 2.50 infusions | Standard Deviation 2.12 |
| CD: New Inflectra | Mean Number of Inflectra Infusions at Visit 4 | 3.11 infusions | Standard Deviation 1.36 |
| CD: Inflectra After Remicade | Mean Number of Inflectra Infusions at Visit 4 | 3.08 infusions | Standard Deviation 0.89 |
| CD: Inflectra After Other Biologics | Mean Number of Inflectra Infusions at Visit 4 | 2.75 infusions | Standard Deviation 1.71 |
Secondary
Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 3 | 17.93 millimeter | Standard Error 4.28 |
| UC: New Inflectra | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 4 | 13.6 millimeter | Standard Error 5.25 |
| UC: New Inflectra | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 2 | 16.68 millimeter | Standard Error 4.12 |
| UC: Inflectra After Remicade | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 3 | 6.49 millimeter | Standard Error 2.23 |
| UC: Inflectra After Remicade | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 2 | 2.31 millimeter | Standard Error 2.41 |
| UC: Inflectra After Remicade | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 4 | 9.88 millimeter | Standard Error 3.31 |
| UC: Inflectra After Other Biologics | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 4 | NA millimeter | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 2 | NA millimeter | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 3 | NA millimeter | — |
| CD: New Inflectra | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 3 | 6.75 millimeter | Standard Error 5.88 |
| CD: New Inflectra | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 2 | 6.16 millimeter | Standard Error 5.97 |
| CD: New Inflectra | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 4 | 13.56 millimeter | Standard Error 6.11 |
| CD: Inflectra After Remicade | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 3 | 0.23 millimeter | Standard Error 2.38 |
| CD: Inflectra After Remicade | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 2 | 0.67 millimeter | Standard Error 2.79 |
| CD: Inflectra After Remicade | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 4 | 1.75 millimeter | Standard Error 1.74 |
| CD: Inflectra After Other Biologics | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 4 | 1.22 millimeter | Standard Error 12.63 |
| CD: Inflectra After Other Biologics | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 3 | 4.89 millimeter | Standard Error 7.44 |
| CD: Inflectra After Other Biologics | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 | Change at Visit 2 | 6.83 millimeter | Standard Error 6.52 |
Secondary
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 3 | 21.23 units on a scale | Standard Error 3.48 |
| UC: New Inflectra | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 2 | 17.52 units on a scale | Standard Error 3.13 |
| UC: New Inflectra | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 4 | 23.57 units on a scale | Standard Error 3.9 |
| UC: Inflectra After Remicade | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 3 | 6.4 units on a scale | Standard Error 1.97 |
| UC: Inflectra After Remicade | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 2 | 4.96 units on a scale | Standard Error 2.2 |
| UC: Inflectra After Remicade | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 4 | 8.29 units on a scale | Standard Error 2.6 |
| UC: Inflectra After Other Biologics | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 3 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 2 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 4 | NA units on a scale | — |
| CD: New Inflectra | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 3 | 7.71 units on a scale | Standard Error 2.88 |
| CD: New Inflectra | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 2 | 6.73 units on a scale | Standard Error 2.34 |
| CD: New Inflectra | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 4 | 9.7 units on a scale | Standard Error 2.62 |
| CD: Inflectra After Remicade | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 3 | 0.46 units on a scale | Standard Error 1.22 |
| CD: Inflectra After Remicade | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 2 | -0.19 units on a scale | Standard Error 1.19 |
| CD: Inflectra After Remicade | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 4 | 0.86 units on a scale | Standard Error 1.75 |
| CD: Inflectra After Other Biologics | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 2 | 12.72 units on a scale | Standard Error 6.19 |
| CD: Inflectra After Other Biologics | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 4 | 11.7 units on a scale | Standard Error 1.57 |
| CD: Inflectra After Other Biologics | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 | Change at Visit 3 | 11.97 units on a scale | Standard Error 5.41 |
Secondary
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 4 | 8.37 units on a scale | Standard Error 5.87 |
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 3 | 6.77 units on a scale | Standard Error 4.42 |
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 2 | 7.08 units on a scale | Standard Error 4.14 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 4 | 4.53 units on a scale | Standard Error 5.59 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 2 | -0.16 units on a scale | Standard Error 4.12 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 3 | 4.55 units on a scale | Standard Error 5.38 |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 2 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 3 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 4 | NA units on a scale | — |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 4 | -1.44 units on a scale | Standard Error 3.95 |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 2 | 0.75 units on a scale | Standard Error 2.77 |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 3 | -4.01 units on a scale | Standard Error 4.66 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 3 | 3.65 units on a scale | Standard Error 3.1 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 2 | 0.57 units on a scale | Standard Error 2.91 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 4 | -1.45 units on a scale | Standard Error 2.97 |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 3 | NA units on a scale | — |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 2 | NA units on a scale | — |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 | Change at Visit 4 | NA units on a scale | — |
Secondary
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 3 | 24.19 units on a scale | Standard Error 6.88 |
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 4 | 28.54 units on a scale | Standard Error 8.55 |
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 2 | 23.33 units on a scale | Standard Error 6.65 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 3 | 10.27 units on a scale | Standard Error 5.27 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 4 | 12.95 units on a scale | Standard Error 5.14 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 2 | 3.27 units on a scale | Standard Error 4.75 |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 4 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 2 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 3 | NA units on a scale | — |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 2 | 12.55 units on a scale | Standard Error 5.25 |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 3 | 14.16 units on a scale | Standard Error 7.54 |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 4 | 24.45 units on a scale | Standard Error 5.98 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 4 | -4.97 units on a scale | Standard Error 5.39 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 2 | -10.73 units on a scale | Standard Error 4.7 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 3 | -6.66 units on a scale | Standard Error 4.48 |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 3 | 11.98 units on a scale | Standard Error 11.77 |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 2 | 12.44 units on a scale | Standard Error 9.98 |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 | Change at Visit 4 | -5.72 units on a scale | Standard Error 19.65 |
Secondary
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 3 | NA units on a scale | — |
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 2 | NA units on a scale | — |
| UC: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 4 | NA units on a scale | — |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 3 | 1.46 units on a scale | Standard Error 4.25 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 2 | 1.23 units on a scale | Standard Error 2.96 |
| UC: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 4 | -5.49 units on a scale | Standard Error 4.25 |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 3 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 2 | NA units on a scale | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 4 | NA units on a scale | — |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 3 | 13.34 units on a scale | Standard Error 3.86 |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 2 | 15.32 units on a scale | Standard Error 5.12 |
| CD: New Inflectra | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 4 | 15.15 units on a scale | Standard Error 5.52 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 3 | -0.3 units on a scale | Standard Error 5.85 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 2 | -1.19 units on a scale | Standard Error 6.23 |
| CD: Inflectra After Remicade | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 4 | 2.93 units on a scale | Standard Error 5.27 |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 2 | NA units on a scale | — |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 4 | NA units on a scale | — |
| CD: Inflectra After Other Biologics | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 | Change at Visit 3 | NA units on a scale | — |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of work time missed | — |
| UC: New Inflectra | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of work time missed | — |
| UC: New Inflectra | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of work time missed | — |
| UC: Inflectra After Remicade | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of work time missed | — |
| UC: Inflectra After Remicade | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of work time missed | — |
| UC: Inflectra After Remicade | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of work time missed | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of work time missed | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of work time missed | — |
| UC: Inflectra After Other Biologics | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of work time missed | — |
| CD: New Inflectra | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of work time missed | — |
| CD: New Inflectra | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of work time missed | — |
| CD: New Inflectra | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of work time missed | — |
| CD: Inflectra After Remicade | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | -2.04 percentage of work time missed | Standard Error 2.36 |
| CD: Inflectra After Remicade | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | -3.68 percentage of work time missed | Standard Error 2.61 |
| CD: Inflectra After Remicade | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | -5.42 percentage of work time missed | Standard Error 2.62 |
| CD: Inflectra After Other Biologics | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of work time missed | — |
| CD: Inflectra After Other Biologics | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of work time missed | — |
| CD: Inflectra After Other Biologics | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of work time missed | — |
Secondary
Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | -43.33 percentage of daily activity impairment | Standard Error 7.66 |
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | -35.51 percentage of daily activity impairment | Standard Error 7.92 |
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | -46.11 percentage of daily activity impairment | Standard Error 8.36 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | -12.73 percentage of daily activity impairment | Standard Error 6.14 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | -14.66 percentage of daily activity impairment | Standard Error 4.39 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | -18.06 percentage of daily activity impairment | Standard Error 6.26 |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of daily activity impairment | — |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of daily activity impairment | — |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of daily activity impairment | — |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | -27.64 percentage of daily activity impairment | Standard Error 6.39 |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | -17.27 percentage of daily activity impairment | Standard Error 6.05 |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | -14.09 percentage of daily activity impairment | Standard Error 6.39 |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | 3.75 percentage of daily activity impairment | Standard Error 3.92 |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | -0.86 percentage of daily activity impairment | Standard Error 4.59 |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | -2.84 percentage of daily activity impairment | Standard Error 6.1 |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of daily activity impairment | — |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of daily activity impairment | — |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of daily activity impairment | — |
Secondary
Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | -30.2 percentage of overall work impairment | Standard Error 10.16 |
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | -22.21 percentage of overall work impairment | Standard Error 11.54 |
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | -38.28 percentage of overall work impairment | Standard Error 10.02 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | -14.93 percentage of overall work impairment | Standard Error 6.5 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | -14.39 percentage of overall work impairment | Standard Error 5.88 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | -18.82 percentage of overall work impairment | Standard Error 5.82 |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of overall work impairment | — |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of overall work impairment | — |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of overall work impairment | — |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of overall work impairment | — |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of overall work impairment | — |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of overall work impairment | — |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | 0.27 percentage of overall work impairment | Standard Error 4.65 |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | 2.33 percentage of overall work impairment | Standard Error 4.7 |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | -4.8 percentage of overall work impairment | Standard Error 4.52 |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of overall work impairment | — |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of overall work impairment | — |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of overall work impairment | — |
Secondary
Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4
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.
Time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | -33.85 percentage of impairment | Standard Error 11.34 |
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | -23.7 percentage of impairment | Standard Error 12 |
| UC: New Inflectra | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | -39.94 percentage of impairment | Standard Error 11.16 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | -13.53 percentage of impairment | Standard Error 6.5 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | -13.18 percentage of impairment | Standard Error 6 |
| UC: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | -17.76 percentage of impairment | Standard Error 5.79 |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of impairment | — |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of impairment | — |
| UC: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of impairment | — |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of impairment | — |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of impairment | — |
| CD: New Inflectra | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of impairment | — |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | 3.91 percentage of impairment | Standard Error 3.91 |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | 1.02 percentage of impairment | Standard Error 4.07 |
| CD: Inflectra After Remicade | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | -2.14 percentage of impairment | Standard Error 4.1 |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 3 | NA percentage of impairment | — |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 2 | NA percentage of impairment | — |
| CD: Inflectra After Other Biologics | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 | Change at Visit 4 | NA percentage of impairment | — |
Secondary
Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease
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.
Time frame: Baseline (before initiation of Inflectra)
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease | 3.95 units on a scale | Standard Deviation 3.15 |
| UC: Inflectra After Remicade | Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease | 3.11 units on a scale | Standard Deviation 3.05 |
| UC: Inflectra After Other Biologics | Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease | 3.57 units on a scale | Standard Deviation 2.51 |
Secondary
Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.94 GE outpatient visits | Standard Deviation 1.76 |
| UC: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.76 GE outpatient visits | Standard Deviation 0.75 |
| UC: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.59 GE outpatient visits | Standard Deviation 0.62 |
| UC: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.58 GE outpatient visits | Standard Deviation 0.79 |
| UC: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.22 GE outpatient visits | Standard Deviation 0.43 |
| UC: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.42 GE outpatient visits | Standard Deviation 0.51 |
| UC: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.48 GE outpatient visits | Standard Deviation 0.6 |
| UC: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.61 GE outpatient visits | Standard Deviation 0.7 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.75 GE outpatient visits | Standard Deviation 0.5 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.67 GE outpatient visits | Standard Deviation 1.21 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.50 GE outpatient visits | Standard Deviation 0.76 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 2.67 GE outpatient visits | Standard Deviation 4.03 |
| CD: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.90 GE outpatient visits | Standard Deviation 1.45 |
| CD: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.62 GE outpatient visits | Standard Deviation 0.65 |
| CD: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.70 GE outpatient visits | Standard Deviation 0.73 |
| CD: New Inflectra | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 1.00 GE outpatient visits | Standard Deviation 0.97 |
| CD: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.36 GE outpatient visits | Standard Deviation 0.68 |
| CD: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.72 GE outpatient visits | Standard Deviation 0.89 |
| CD: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.47 GE outpatient visits | Standard Deviation 0.7 |
| CD: Inflectra After Remicade | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.28 GE outpatient visits | Standard Deviation 0.74 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 1.11 GE outpatient visits | Standard Deviation 0.78 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.67 GE outpatient visits | Standard Deviation 0.52 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 1.20 GE outpatient visits | Standard Deviation 0.84 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 1.00 GE outpatient visits | Standard Deviation 1.63 |
Secondary
Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.42 GP outpatient visits | Standard Deviation 0.67 |
| UC: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.41 GP outpatient visits | Standard Deviation 0.51 |
| UC: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.33 GP outpatient visits | Standard Deviation 0.84 |
| UC: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.29 GP outpatient visits | Standard Deviation 0.47 |
| UC: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.56 GP outpatient visits | Standard Deviation 0.86 |
| UC: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.33 GP outpatient visits | Standard Deviation 0.8 |
| UC: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.63 GP outpatient visits | Standard Deviation 0.76 |
| UC: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.17 GP outpatient visits | Standard Deviation 0.38 |
| UC: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.50 GP outpatient visits | Standard Deviation 0.76 |
| UC: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 1.50 GP outpatient visits | Standard Deviation 1.29 |
| UC: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 1.33 GP outpatient visits | Standard Deviation 3.64 |
| UC: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 1.00 GP outpatient visits | Standard Deviation 1.26 |
| CD: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.65 GP outpatient visits | Standard Deviation 0.93 |
| CD: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.46 GP outpatient visits | Standard Deviation 0.78 |
| CD: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.25 GP outpatient visits | Standard Deviation 0.45 |
| CD: New Inflectra | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.05 GP outpatient visits | Standard Deviation 0.22 |
| CD: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.33 GP outpatient visits | Standard Deviation 0.59 |
| CD: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.38 GP outpatient visits | Standard Deviation 0.75 |
| CD: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.64 GP outpatient visits | Standard Deviation 0.96 |
| CD: Inflectra After Remicade | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.22 GP outpatient visits | Standard Deviation 0.54 |
| CD: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 1.40 GP outpatient visits | Standard Deviation 2.07 |
| CD: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.10 GP outpatient visits | Standard Deviation 0.32 |
| CD: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.22 GP outpatient visits | Standard Deviation 0.44 |
| CD: Inflectra After Other Biologics | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.33 GP outpatient visits | Standard Deviation 0.52 |
Secondary
Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4
In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 1 | 0.17 hospitalization visits | Standard Deviation 0.38 |
| UC: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 2 | 0.06 hospitalization visits | Standard Deviation 0.24 |
| UC: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 3 | 0.00 hospitalization visits | Standard Deviation 0 |
| UC: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 4 | 0.00 hospitalization visits | Standard Deviation 0 |
| UC: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 3 | 0.06 hospitalization visits | Standard Deviation 0.24 |
| UC: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 2 | 0.00 hospitalization visits | Standard Deviation 0 |
| UC: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 1 | 0.00 hospitalization visits | Standard Deviation 0 |
| UC: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 4 | 0.00 hospitalization visits | Standard Deviation 0 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 4 | 0.00 hospitalization visits | Standard Deviation 0 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 3 | 0.17 hospitalization visits | Standard Deviation 0.41 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 2 | 0.00 hospitalization visits | Standard Deviation 0 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 1 | 0.33 hospitalization visits | Standard Deviation 0.71 |
| CD: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 1 | 0.24 hospitalization visits | Standard Deviation 0.54 |
| CD: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 4 | 0.08 hospitalization visits | Standard Deviation 0.28 |
| CD: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 2 | 0.05 hospitalization visits | Standard Deviation 0.22 |
| CD: New Inflectra | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 3 | 0.06 hospitalization visits | Standard Deviation 0.25 |
| CD: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 3 | 0.00 hospitalization visits | Standard Deviation 0 |
| CD: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 4 | 0.03 hospitalization visits | Standard Deviation 0.18 |
| CD: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 2 | 0.17 hospitalization visits | Standard Deviation 0.51 |
| CD: Inflectra After Remicade | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 1 | 0.00 hospitalization visits | Standard Deviation 0 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 2 | 0.22 hospitalization visits | Standard Deviation 0.67 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 3 | 0.00 hospitalization visits | Standard Deviation 0 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 4 | 0.40 hospitalization visits | Standard Deviation 0.89 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 | Visit 1 | 0.40 hospitalization visits | Standard Deviation 0.52 |
Secondary
Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 2.06 outpatient visits | Standard Deviation 5.34 |
| UC: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 1.41 outpatient visits | Standard Deviation 1.33 |
| UC: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 1.18 outpatient visits | Standard Deviation 1.33 |
| UC: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 1.08 outpatient visits | Standard Deviation 1.16 |
| UC: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.61 outpatient visits | Standard Deviation 0.98 |
| UC: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 1.37 outpatient visits | Standard Deviation 1.42 |
| UC: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 1.10 outpatient visits | Standard Deviation 1.95 |
| UC: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 1.33 outpatient visits | Standard Deviation 1.33 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 3.00 outpatient visits | Standard Deviation 1.41 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 2.50 outpatient visits | Standard Deviation 3.21 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 1.38 outpatient visits | Standard Deviation 1.3 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 4.22 outpatient visits | Standard Deviation 7.51 |
| CD: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 1.05 outpatient visits | Standard Deviation 1.56 |
| CD: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 1.31 outpatient visits | Standard Deviation 1.18 |
| CD: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 1.60 outpatient visits | Standard Deviation 1.54 |
| CD: New Inflectra | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 1.56 outpatient visits | Standard Deviation 1.15 |
| CD: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.97 outpatient visits | Standard Deviation 1.54 |
| CD: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 1.47 outpatient visits | Standard Deviation 1.5 |
| CD: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 1.33 outpatient visits | Standard Deviation 1.39 |
| CD: Inflectra After Remicade | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.78 outpatient visits | Standard Deviation 1.55 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 2 | 1.44 outpatient visits | Standard Deviation 1.13 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 3 | 1.00 outpatient visits | Standard Deviation 0.89 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 4 | 3.40 outpatient visits | Standard Deviation 3.91 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 | Visit 1 | 1.80 outpatient visits | Standard Deviation 3.49 |
Secondary
Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.22 emergency department visits | Standard Deviation 0.43 |
| UC: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.06 emergency department visits | Standard Deviation 0.24 |
| UC: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.06 emergency department visits | Standard Deviation 0.24 |
| UC: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.00 emergency department visits | Standard Deviation 0 |
| UC: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.00 emergency department visits | Standard Deviation 0 |
| UC: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.05 emergency department visits | Standard Deviation 0.23 |
| UC: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.10 emergency department visits | Standard Deviation 0.44 |
| UC: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.00 emergency department visits | Standard Deviation 0 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.00 emergency department visits | Standard Deviation 0 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.00 emergency department visits | Standard Deviation 0 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.25 emergency department visits | Standard Deviation 0.71 |
| UC: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.11 emergency department visits | Standard Deviation 0.33 |
| CD: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.14 emergency department visits | Standard Deviation 0.36 |
| CD: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.00 emergency department visits | Standard Deviation 0 |
| CD: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.35 emergency department visits | Standard Deviation 1.35 |
| CD: New Inflectra | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.06 emergency department visits | Standard Deviation 0.25 |
| CD: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.03 emergency department visits | Standard Deviation 0.17 |
| CD: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.09 emergency department visits | Standard Deviation 0.53 |
| CD: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.11 emergency department visits | Standard Deviation 0.4 |
| CD: Inflectra After Remicade | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.03 emergency department visits | Standard Deviation 0.17 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 2 | 0.00 emergency department visits | Standard Deviation 0 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 3 | 0.00 emergency department visits | Standard Deviation 0 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 4 | 0.80 emergency department visits | Standard Deviation 1.1 |
| CD: Inflectra After Other Biologics | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 | Visit 1 | 0.20 emergency department visits | Standard Deviation 0.42 |
Secondary
Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis
Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).
Time frame: Baseline (before initiation of Inflectra)
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E1 Ulcerative proctitis | 3 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E2 Left-sided UC | 6 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E3 Extensive UC | 8 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | Unknown | 1 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | Unknown | 1 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E1 Ulcerative proctitis | 1 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E3 Extensive UC | 16 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E2 Left-sided UC | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | Unknown | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E2 Left-sided UC | 4 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E3 Extensive UC | 4 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis | E1 Ulcerative proctitis | 1 Participants |
Secondary
Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease
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 \[GI\]).
Time frame: Baseline (before initiation of Inflectra)
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B2 Stricturing | 4 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L3 Ileocolon | 8 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B3 Penetrating | 4 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: P Perianal disease | 0 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L1 Terminal ileum | 7 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: Unknown | 2 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L4 Upper GI | 0 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L2 Colon | 6 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: Unknown | 0 Participants |
| UC: New Inflectra | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B1 Nonstricturing, nonpenetrating | 11 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B2 Stricturing | 6 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L4 Upper GI | 1 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B1 Nonstricturing, nonpenetrating | 3 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B3 Penetrating | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L3 Ileocolon | 7 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L1 Terminal ileum | 12 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: P Perianal disease | 2 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: Unknown | 4 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: Unknown | 25 Participants |
| UC: Inflectra After Remicade | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L2 Colon | 12 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: Unknown | 1 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L1 Terminal ileum | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L2 Colon | 4 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L3 Ileocolon | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: L4 Upper GI | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Location: Unknown | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B1 Nonstricturing, nonpenetrating | 6 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B2 Stricturing | 1 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: B3 Penetrating | 1 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease | Behavior: P Perianal disease | 1 Participants |
Secondary
Number of Participants With Any 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.
Time frame: Visit 1 to 4 (approximately 1 year)
Population: The safety analysis set included all participants who signed an informed consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UC: New Inflectra | Number of Participants With Any Serious Adverse Event | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants With Any Serious Adverse Event | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Any Serious Adverse Event | 1 Participants |
| CD: New Inflectra | Number of Participants With Any Serious Adverse Event | 5 Participants |
| CD: Inflectra After Remicade | Number of Participants With Any Serious Adverse Event | 8 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Any Serious Adverse Event | 2 Participants |
Secondary
Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 1 | 13 Participants |
| UC: New Inflectra | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 2 | 16 Participants |
| UC: New Inflectra | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 3 | 12 Participants |
| UC: New Inflectra | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 4 | 11 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 4 | 23 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 1 | 28 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 3 | 24 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 2 | 23 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 4 | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 2 | 8 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 3 | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 | Visit 1 | 7 Participants |
Secondary
Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 1 | 0 Participants |
| UC: New Inflectra | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 2 | 4 Participants |
| UC: New Inflectra | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 3 | 5 Participants |
| UC: New Inflectra | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 4 | 4 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 4 | 2 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 1 | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 3 | 4 Participants |
| UC: Inflectra After Remicade | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 2 | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 4 | 1 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 2 | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 3 | 2 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 | Visit 1 | 0 Participants |
Secondary
Number of Participants With Infections
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.
Time frame: Visit 1 to 4 (approximately 1 year)
Population: The safety analysis set included all participants who signed an informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Infections | All Infections | 0 Participants |
| UC: New Inflectra | Number of Participants With Infections | Serious Infections | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants With Infections | All Infections | 1 Participants |
| UC: Inflectra After Remicade | Number of Participants With Infections | Serious Infections | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Infections | All Infections | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Infections | Serious Infections | 0 Participants |
| CD: New Inflectra | Number of Participants With Infections | All Infections | 0 Participants |
| CD: New Inflectra | Number of Participants With Infections | Serious Infections | 0 Participants |
| CD: Inflectra After Remicade | Number of Participants With Infections | All Infections | 0 Participants |
| CD: Inflectra After Remicade | Number of Participants With Infections | Serious Infections | 0 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Infections | All Infections | 0 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Infections | Serious Infections | 0 Participants |
Secondary
Number of Participants With Infusion-related Reactions
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.
Time frame: Visit 1 to 4 (approximately 1 year)
Population: The safety analysis set included all participants who signed an informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Infusion-related Reactions | Infusion-related reactions (serious adverse event) | 0 Participants |
| UC: New Inflectra | Number of Participants With Infusion-related Reactions | Infusion-related reactions (non-serious adverse event) | 1 Participants |
| UC: Inflectra After Remicade | Number of Participants With Infusion-related Reactions | Infusion-related reactions (serious adverse event) | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants With Infusion-related Reactions | Infusion-related reactions (non-serious adverse event) | 1 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Infusion-related Reactions | Infusion-related reactions (serious adverse event) | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Infusion-related Reactions | Infusion-related reactions (non-serious adverse event) | 0 Participants |
| CD: New Inflectra | Number of Participants With Infusion-related Reactions | Infusion-related reactions (serious adverse event) | 0 Participants |
| CD: New Inflectra | Number of Participants With Infusion-related Reactions | Infusion-related reactions (non-serious adverse event) | 0 Participants |
| CD: Inflectra After Remicade | Number of Participants With Infusion-related Reactions | Infusion-related reactions (serious adverse event) | 0 Participants |
| CD: Inflectra After Remicade | Number of Participants With Infusion-related Reactions | Infusion-related reactions (non-serious adverse event) | 0 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Infusion-related Reactions | Infusion-related reactions (serious adverse event) | 0 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Infusion-related Reactions | Infusion-related reactions (non-serious adverse event) | 0 Participants |
Secondary
Number of Participants With Malignancy and Lymphoma
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.
Time frame: Visit 1 to 4 (approximately 1 year)
Population: The safety analysis set included all participants who signed an informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Serious Adverse Event) | 0 Participants |
| UC: New Inflectra | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Non-serious Adverse Event) | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Serious Adverse Event) | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Non-serious Adverse Event) | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Serious Adverse Event) | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Non-serious Adverse Event) | 0 Participants |
| CD: New Inflectra | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Serious Adverse Event) | 0 Participants |
| CD: New Inflectra | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Non-serious Adverse Event) | 1 Participants |
| CD: Inflectra After Remicade | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Serious Adverse Event) | 3 Participants |
| CD: Inflectra After Remicade | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Non-serious Adverse Event) | 0 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Serious Adverse Event) | 0 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Malignancy and Lymphoma | Malignancy and Lymphoma (Non-serious Adverse Event) | 0 Participants |
Secondary
Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 1 | 1 Participants |
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 2 | 14 Participants |
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 3 | 12 Participants |
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 4 | 10 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 4 | 16 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 1 | 15 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 3 | 14 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 2 | 16 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 4 | 1 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 2 | 4 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 3 | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 | Visit 1 | 1 Participants |
Secondary
Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4
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.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 2 | 12 Participants |
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 4 | 8 Participants |
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 3 | 13 Participants |
| UC: New Inflectra | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 1 | 0 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 3 | 2 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 4 | 2 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 2 | 2 Participants |
| UC: Inflectra After Remicade | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 1 | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 4 | 2 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 1 | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 3 | 3 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 | Visit 2 | 4 Participants |
Secondary
Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis
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.
Time frame: Baseline (before initiation of Inflectra)
Population: The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis | 5.67 units on a scale | Standard Deviation 2.25 |
| UC: Inflectra After Remicade | Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis | 1.38 units on a scale | Standard Deviation 1.83 |
| UC: Inflectra After Other Biologics | Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis | 6.00 units on a scale | Standard Deviation 2.65 |
Other Pre-specified
Duration of Inflectra Therapy
In this outcome measure duration of Inflectra treatment (in months) is reported.
Time frame: Visit 1 to 4 (approximately 1 year)
Population: The safety analysis set included all participants who signed an informed consent. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC: New Inflectra | Duration of Inflectra Therapy | 11.13 months | Standard Deviation 3.71 |
| UC: Inflectra After Remicade | Duration of Inflectra Therapy | 10.42 months | Standard Deviation 3.67 |
| UC: Inflectra After Other Biologics | Duration of Inflectra Therapy | 8.90 months | Standard Deviation 4.4 |
| CD: New Inflectra | Duration of Inflectra Therapy | 10.37 months | Standard Deviation 3.22 |
| CD: Inflectra After Remicade | Duration of Inflectra Therapy | 11.83 months | Standard Deviation 2.27 |
| CD: Inflectra After Other Biologics | Duration of Inflectra Therapy | 9.59 months | Standard Deviation 3.7 |
Other Pre-specified
Number of Participants Who Completed Each Study Visit
In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 1 | 18 Participants |
| UC: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 4 | 12 Participants |
| UC: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 3 | 17 Participants |
| UC: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 2 | 17 Participants |
| UC: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 4 | 18 Participants |
| UC: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 2 | 19 Participants |
| UC: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 1 | 21 Participants |
| UC: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 3 | 18 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 3 | 6 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 2 | 8 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 1 | 9 Participants |
| UC: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 4 | 4 Participants |
| CD: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 3 | 16 Participants |
| CD: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 2 | 20 Participants |
| CD: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 1 | 21 Participants |
| CD: New Inflectra | Number of Participants Who Completed Each Study Visit | Visit 4 | 13 Participants |
| CD: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 4 | 32 Participants |
| CD: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 2 | 36 Participants |
| CD: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 1 | 36 Participants |
| CD: Inflectra After Remicade | Number of Participants Who Completed Each Study Visit | Visit 3 | 36 Participants |
| CD: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 2 | 9 Participants |
| CD: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 1 | 10 Participants |
| CD: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 4 | 5 Participants |
| CD: Inflectra After Other Biologics | Number of Participants Who Completed Each Study Visit | Visit 3 | 6 Participants |
Other Pre-specified
Number of Participants With Any Changes in Dosing
In this outcome measure, number of participants who had any changes in dosing are reported.
Time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
Population: The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 3 | 5 Participants |
| UC: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 2 | 6 Participants |
| UC: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 1 | 3 Participants |
| UC: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 4 | 3 Participants |
| UC: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 4 | 2 Participants |
| UC: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 2 | 4 Participants |
| UC: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 1 | 5 Participants |
| UC: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 3 | 2 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 2 | 4 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 4 | 1 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 1 | 0 Participants |
| UC: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 3 | 2 Participants |
| CD: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 4 | 6 Participants |
| CD: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 3 | 3 Participants |
| CD: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 2 | 10 Participants |
| CD: New Inflectra | Number of Participants With Any Changes in Dosing | Visit 1 | 1 Participants |
| CD: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 1 | 7 Participants |
| CD: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 2 | 1 Participants |
| CD: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 3 | 3 Participants |
| CD: Inflectra After Remicade | Number of Participants With Any Changes in Dosing | Visit 4 | 4 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 3 | 1 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 2 | 4 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 4 | 2 Participants |
| CD: Inflectra After Other Biologics | Number of Participants With Any Changes in Dosing | Visit 1 | 1 Participants |