Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Duration of Inflectra Therapy |
In this outcome measure duration of Inflectra treatment (in months) is reported. |
Visit 1 to 4 (approximately 1 year) |
|
| Other |
Number of Participants With Any Changes in Dosing |
In this outcome measure, number of participants who had any changes in dosing are reported. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| Other |
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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| Primary |
Average Dose of Inflectra at Visit 1 |
|
Visit 1= Day 1 |
|
| Primary |
Average Dose of Inflectra at Visit 2 |
|
Visit 2= Day 90 |
|
| Primary |
Average Dose of Inflectra at Visit 3 |
|
Visit 3= Day 180 |
|
| Primary |
Average Dose of Inflectra at Visit 4 |
|
Visit 4= Day 365 |
|
| Primary |
Mean Number of Inflectra Infusions at Visit 1 |
|
Visit 1= Day 1 |
|
| Primary |
Mean Number of Inflectra Infusions at Visit 2 |
|
Visit 2= Day 90 |
|
| Primary |
Mean Number of Inflectra Infusions at Visit 3 |
|
Visit 3= Day 180 |
|
| Primary |
Mean Number of Inflectra Infusions at Visit 4 |
|
Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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. |
Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365 |
|
| 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). |
Baseline (before initiation of Inflectra) |
|
| 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]). |
Baseline (before initiation of Inflectra) |
|
| 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. |
Baseline (before initiation of Inflectra) |
|
| 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. |
Baseline (before initiation of Inflectra) |
|
| 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. |
Visit 1 to 4 (approximately 1 year) |
|
| 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. |
Visit 1 to 4 (approximately 1 year) |
|
| 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. |
Visit 1 to 4 (approximately 1 year) |
|
| 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. |
Visit 1 to 4 (approximately 1 year) |
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