ONWARD: Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03801928
Collaborator
(none)
118
15
23.5
7.9
0.3
Study Details
Study Description
Brief Summary
This is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in the United States and Canada in which the participating physician has decided to treat with INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with INFLECTRA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
118 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA
Actual Study Start Date
:
Feb 23, 2018
Actual Primary Completion Date
:
Feb 7, 2020
Actual Study Completion Date
:
Feb 7, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ulcerative Colitis Group treated with Inflectra for Ulcerative Colitis |
Drug: Inflectra
The study plans to recruit 300 subjects in the United States and Canada initiating or switching to treatment with INFLECTRA over an 8 month period. The decision to start INFLECTRA will be entirely a clinical decision made by the participating physician irrespective of this study.
Other Names:
|
| Crohn's Disease Group treated with Inflectra for Crohn's Disease |
Drug: Inflectra
The study plans to recruit 300 subjects in the United States and Canada initiating or switching to treatment with INFLECTRA over an 8 month period. The decision to start INFLECTRA will be entirely a clinical decision made by the participating physician irrespective of this study.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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]
- Mean Number of Inflectra Infusions at Visit 2 [Visit 2= Day 90]
- Mean Number of Inflectra Infusions at Visit 3 [Visit 3= Day 180]
- Mean Number of Inflectra Infusions at Visit 4 [Visit 4= Day 365]
Secondary Outcome Measures
- 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.
- 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.
- Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 [Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365]
Participants with a confirmed diagnosis of UC, were said to have response when there was a reduction of partial Mayo score of >=3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.
- Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 [Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365]
This questionnaire is designed to find out how participants felt during the last 2 weeks. Participants were asked 10 questions about physical, social, and emotional status. Participants had to respond for every question on a scale from 1 (poor) to 7 (good). Total SIBDQ score was sum of scores from 10 questions, with range from 10 (poor quality of life) to 70 (optimum quality of life), higher values indicated better well-being.
- Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 [Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365]
Participants were asked to mark their overall well-being at specified visits on a scale from 0 millimeter to 100 millimeter. 0 indicated worst health and 100 indicated perfect health. Higher scores indicated better well-being.
- Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis [Baseline (before initiation of Inflectra)]
Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).
- Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease [Baseline (before initiation of Inflectra)]
Participants with Montreal classification for CD was reported for behavior (B1: nonstricturing, no penetrating, B2: structuring, B3: penetrating, P: perianal disease, unknown) and location (L1: terminal ileum, L2: colon, L3: ileocolon, L4: upper gastrointestinal [GI]).
- Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis [Baseline (before initiation of Inflectra)]
PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.
- 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.
Other Outcome Measures
- 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 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for inclusion in the study:
-
Patients with confirmed diagnosis of Ulcerative Colitis or Crohn's Disease.
-
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
-
Patient eligible to receive INFLECTRA for the treatment of their disease per approved drug label (patients with fistula, or stoma are eligible).
Exclusion Criteria:
-Patients meeting any of the following criteria will not be included in the study:
-
Patient previously failed treatment with REMICADE or INFLECTRA/CT P13.
-
Any reported contraindications for INFLECTRA/CT P13 or REMICADE.
-
Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Diego Clinical Trials | San Diego | California | United States | 92120 |
| 2 | Medical Research Center Of Connecticut, LLC | Hamden | Connecticut | United States | 06518 |
| 3 | Suncoast Research Group, LLC | Miami | Florida | United States | 33135 |
| 4 | Illinois Gastroenterology Group | Gurnee | Illinois | United States | 60031 |
| 5 | Indiana University Health Division of Gastroenterology/Hepatology | Indianapolis | Indiana | United States | 46202 |
| 6 | Gastro Center of Maryland | Columbia | Maryland | United States | 21045 |
| 7 | Infusion Associates N.E. | Grand Rapids | Michigan | United States | 49525 |
| 8 | Trinity Health Center Medical Arts | Minot | North Dakota | United States | 58701 |
| 9 | Dayton Gastroenterology, Inc. | Beavercreek | Ohio | United States | 45440 |
| 10 | Paramount Medical Research & consulting, LLC | Middleburg Heights | Ohio | United States | 44130 |
| 11 | The Vancouver Clinic Research | Vancouver | Washington | United States | 98664 |
| 12 | Aspen Woods Clinic | Calgary | Alberta | Canada | T3H 0V5 |
| 13 | Brennan Walters Professional Corporation | Edmonton | Alberta | Canada | T5R 1W2 |
| 14 | Fraser Clinical Trials | New Westminster | British Columbia | Canada | V3L 3W5 |
| 15 | Montreal IBD Center (CMIIM) | Montreal | Quebec | Canada | H2V 2X1 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03801928
Other Study ID Numbers:
- C1231006
- ONWARD
First Posted:
Jan 14, 2019
Last Update Posted:
Mar 2, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
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 Detail | 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. |
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Period Title: Overall Study | ||||||
| STARTED | 18 | 21 | 9 | 21 | 36 | 10 |
| COMPLETED | 12 | 18 | 4 | 13 | 32 | 5 |
| NOT COMPLETED | 6 | 3 | 5 | 8 | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 18 | 21 | 9 | 21 | 36 | 10 | 115 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Years] |
44.94
(17.72)
|
41.76
(12.68)
|
51.67
(16.39)
|
46.86
(17.98)
|
43.40
(17.02)
|
39.00
(14.51)
|
44.25
(16.29)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
8
44.4%
|
12
57.1%
|
6
66.7%
|
8
38.1%
|
19
52.8%
|
6
60%
|
59
51.3%
|
| Male |
10
55.6%
|
9
42.9%
|
3
33.3%
|
13
61.9%
|
17
47.2%
|
4
40%
|
56
48.7%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||
| Asian |
0
0%
|
0
0%
|
1
11.1%
|
1
4.8%
|
1
2.8%
|
0
0%
|
3
2.6%
|
| Black or African American |
0
0%
|
1
4.8%
|
1
11.1%
|
2
9.5%
|
3
8.3%
|
1
10%
|
8
7%
|
| White or Caucasian American |
16
88.9%
|
20
95.2%
|
6
66.7%
|
18
85.7%
|
31
86.1%
|
9
90%
|
100
87%
|
| Other |
2
11.1%
|
0
0%
|
1
11.1%
|
0
0%
|
1
2.8%
|
0
0%
|
4
3.5%
|
| Insurance Plan Coverage (Count of Participants) | |||||||
| Canada Medicare |
4
22.2%
|
0
0%
|
4
44.4%
|
4
19%
|
0
0%
|
4
40%
|
16
13.9%
|
| Health Maintenance Organization (HMO) |
2
11.1%
|
18
85.7%
|
0
0%
|
2
9.5%
|
22
61.1%
|
2
20%
|
46
40%
|
| Medicare/Medicaid |
3
16.7%
|
3
14.3%
|
3
33.3%
|
6
28.6%
|
9
25%
|
1
10%
|
25
21.7%
|
| Point of Service Plan (POS) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
1
0.9%
|
| Preferred Provider Organization (PPO) |
9
50%
|
0
0%
|
2
22.2%
|
9
42.9%
|
4
11.1%
|
2
20%
|
26
22.6%
|
| Unknown |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.8%
|
0
0%
|
1
0.9%
|
| Surgical History (Count of Participants) | |||||||
| Count of Participants [Participants] |
0
0%
|
2
9.5%
|
0
0%
|
4
19%
|
15
41.7%
|
3
30%
|
24
20.9%
|
| Disease Duration (Years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Years] |
5.96
(6.40)
|
8.88
(8.86)
|
10.00
(9.11)
|
5.89
(6.30)
|
10.59
(10.28)
|
7.22
(7.45)
|
8.26
(8.47)
|
| Medication History (Count of Participants) | |||||||
| Count of Participants [Participants] |
0
0%
|
21
100%
|
9
100%
|
1
4.8%
|
36
100%
|
9
90%
|
76
66.1%
|
| Concomitant Medication Usage (Count of Participants) | |||||||
| Count of Participants [Participants] |
18
100%
|
14
66.7%
|
7
77.8%
|
18
85.7%
|
16
44.4%
|
9
90%
|
82
71.3%
|
Outcome Measures
| Title | Average Dose of Inflectra at Visit 1 |
|---|---|
| Description | |
| Time Frame | Visit 1= Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 35 | 10 |
| Mean (Standard Deviation) [milligram] |
457.28
(184.03)
|
585.71
(305.43)
|
579.44
(193.69)
|
449.76
(102.33)
|
521.83
(274.76)
|
534.90
(171.15)
|
| Title | Average Dose of Inflectra at Visit 2 |
|---|---|
| Description | |
| Time Frame | Visit 2= Day 90 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 17 | 17 | 8 | 20 | 32 | 8 |
| Mean (Standard Deviation) [milligram] |
491.66
(201.43)
|
535.29
(259.67)
|
662.36
(194.54)
|
491.62
(172.95)
|
506.97
(236.03)
|
575.00
(210.76)
|
| Title | Average Dose of Inflectra at Visit 3 |
|---|---|
| Description | |
| Time Frame | Visit 3= Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 16 | 16 | 5 | 15 | 30 | 5 |
| Mean (Standard Deviation) [milligram] |
556.34
(216.05)
|
531.25
(270.11)
|
647.67
(328.73)
|
517.87
(162.06)
|
544.40
(233.21)
|
621.00
(230.55)
|
| Title | Average Dose of Inflectra at Visit 4 |
|---|---|
| Description | |
| Time Frame | Visit 4= Day 365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 9 | 15 | 2 | 9 | 26 | 4 |
| Mean (Standard Deviation) [milligram] |
409.28
(216.59)
|
552.00
(270.43)
|
450.00
(70.71)
|
536.12
(216.39)
|
553.20
(238.22)
|
610.15
(229.08)
|
| Title | Mean Number of Inflectra Infusions at Visit 1 |
|---|---|
| Description | |
| Time Frame | Visit 1= Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 35 | 10 |
| Mean (Standard Deviation) [infusions] |
1.56
(0.62)
|
1.00
(0.00)
|
1.44
(0.53)
|
1.43
(0.51)
|
1.11
(0.32)
|
1.70
(0.67)
|
| Title | Mean Number of Inflectra Infusions at Visit 2 |
|---|---|
| Description | |
| Time Frame | Visit 2= Day 90 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 17 | 17 | 8 | 20 | 32 | 8 |
| Mean (Standard Deviation) [infusions] |
2.06
(0.75)
|
1.76
(0.44)
|
2.38
(1.06)
|
1.95
(0.83)
|
1.47
(0.51)
|
2.00
(0.53)
|
| Title | Mean Number of Inflectra Infusions at Visit 3 |
|---|---|
| Description | |
| Time Frame | Visit 3= Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 16 | 16 | 5 | 15 | 30 | 5 |
| Mean (Standard Deviation) [infusions] |
1.56
(0.63)
|
1.38
(0.62)
|
2.20
(1.30)
|
1.47
(0.83)
|
1.40
(0.50)
|
1.40
(0.55)
|
| Title | Mean Number of Inflectra Infusions at Visit 4 |
|---|---|
| Description | |
| Time Frame | Visit 4= Day 365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 9 | 15 | 2 | 9 | 26 | 4 |
| Mean (Standard Deviation) [infusions] |
2.56
(0.88)
|
3.00
(0.85)
|
2.50
(2.12)
|
3.11
(1.36)
|
3.08
(0.89)
|
2.75
(1.71)
|
| Title | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
-3.68
(2.61)
|
NA
(NA)
|
| Change at Visit 3 |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
-2.04
(2.36)
|
NA
(NA)
|
| Change at Visit 4 |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
-5.42
(2.62)
|
NA
(NA)
|
| Title | Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
-23.7
(12)
|
-13.18
(6)
|
NA
(NA)
|
NA
(NA)
|
3.91
(3.91)
|
NA
(NA)
|
| Change at Visit 3 |
-33.85
(11.34)
|
-13.53
(6.5)
|
NA
(NA)
|
NA
(NA)
|
1.02
(4.07)
|
NA
(NA)
|
| Change at Visit 4 |
-39.94
(11.16)
|
-17.76
(5.79)
|
NA
(NA)
|
NA
(NA)
|
-2.14
(4.1)
|
NA
(NA)
|
| Title | Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
-22.21
(11.54)
|
-14.39
(5.88)
|
NA
(NA)
|
NA
(NA)
|
2.33
(4.7)
|
NA
(NA)
|
| Change at Visit 3 |
-30.2
(10.16)
|
-14.93
(6.5)
|
NA
(NA)
|
NA
(NA)
|
0.27
(4.65)
|
NA
(NA)
|
| Change at Visit 4 |
-38.28
(10.02)
|
-18.82
(5.82)
|
NA
(NA)
|
NA
(NA)
|
-4.8
(4.52)
|
NA
(NA)
|
| Title | Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
-35.51
(7.92)
|
-14.66
(4.39)
|
NA
(NA)
|
-17.27
(6.05)
|
3.75
(3.92)
|
NA
(NA)
|
| Change at Visit 3 |
-43.33
(7.66)
|
-12.73
(6.14)
|
NA
(NA)
|
-14.09
(6.39)
|
-0.86
(4.59)
|
NA
(NA)
|
| Change at Visit 4 |
-46.11
(8.36)
|
-18.06
(6.26)
|
NA
(NA)
|
-27.64
(6.39)
|
-2.84
(6.1)
|
NA
(NA)
|
| Title | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
7.08
(4.14)
|
-0.16
(4.12)
|
NA
(NA)
|
0.75
(2.77)
|
0.57
(2.91)
|
NA
(NA)
|
| Change at Visit 3 |
6.77
(4.42)
|
4.55
(5.38)
|
NA
(NA)
|
-4.01
(4.66)
|
3.65
(3.1)
|
NA
(NA)
|
| Change at Visit 4 |
8.37
(5.87)
|
4.53
(5.59)
|
NA
(NA)
|
-1.44
(3.95)
|
-1.45
(2.97)
|
NA
(NA)
|
| Title | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
23.33
(6.65)
|
3.27
(4.75)
|
NA
(NA)
|
12.55
(5.25)
|
-10.73
(4.7)
|
12.44
(9.98)
|
| Change at Visit 3 |
24.19
(6.88)
|
10.27
(5.27)
|
NA
(NA)
|
14.16
(7.54)
|
-6.66
(4.48)
|
11.98
(11.77)
|
| Change at Visit 4 |
28.54
(8.55)
|
12.95
(5.14)
|
NA
(NA)
|
24.45
(5.98)
|
-4.97
(5.39)
|
-5.72
(19.65)
|
| Title | Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
NA
(NA)
|
1.23
(2.96)
|
NA
(NA)
|
15.32
(5.12)
|
-1.19
(6.23)
|
NA
(NA)
|
| Change at Visit 3 |
NA
(NA)
|
1.46
(4.25)
|
NA
(NA)
|
13.34
(3.86)
|
-0.3
(5.85)
|
NA
(NA)
|
| Change at Visit 4 |
NA
(NA)
|
-5.49
(4.25)
|
NA
(NA)
|
15.15
(5.52)
|
2.93
(5.27)
|
NA
(NA)
|
| Title | Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Visit 1 |
0.17
(0.38)
|
0.00
(0.00)
|
0.33
(0.71)
|
0.24
(0.54)
|
0.00
(0.00)
|
0.40
(0.52)
|
| Visit 2 |
0.06
(0.24)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.05
(0.22)
|
0.17
(0.51)
|
0.22
(0.67)
|
| Visit 3 |
0.00
(0.00)
|
0.06
(0.24)
|
0.17
(0.41)
|
0.06
(0.25)
|
0.00
(0.00)
|
0.00
(0.00)
|
| Visit 4 |
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.08
(0.28)
|
0.03
(0.18)
|
0.40
(0.89)
|
| Title | Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Visit 1 |
0.22
(0.43)
|
0.10
(0.44)
|
0.11
(0.33)
|
0.14
(0.36)
|
0.03
(0.17)
|
0.20
(0.42)
|
| Visit 2 |
0.06
(0.24)
|
0.05
(0.23)
|
0.25
(0.71)
|
0.35
(1.35)
|
0.11
(0.40)
|
0.00
(0.00)
|
| Visit 3 |
0.06
(0.24)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.06
(0.25)
|
0.03
(0.17)
|
0.00
(0.00)
|
| Visit 4 |
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.09
(0.53)
|
0.80
(1.10)
|
| Title | Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Visit 1 |
2.06
(5.34)
|
1.10
(1.95)
|
4.22
(7.51)
|
1.05
(1.56)
|
0.78
(1.55)
|
1.80
(3.49)
|
| Visit 2 |
1.41
(1.33)
|
1.37
(1.42)
|
1.38
(1.30)
|
1.60
(1.54)
|
1.33
(1.39)
|
1.44
(1.13)
|
| Visit 3 |
1.18
(1.33)
|
0.61
(0.98)
|
2.50
(3.21)
|
1.56
(1.15)
|
0.97
(1.54)
|
1.00
(0.89)
|
| Visit 4 |
1.08
(1.16)
|
1.33
(1.33)
|
3.00
(1.41)
|
1.31
(1.18)
|
1.47
(1.50)
|
3.40
(3.91)
|
| Title | Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Visit 1 |
0.94
(1.76)
|
0.48
(0.60)
|
2.67
(4.03)
|
0.90
(1.45)
|
0.28
(0.74)
|
1.00
(1.63)
|
| Visit 2 |
0.76
(0.75)
|
0.42
(0.51)
|
0.50
(0.76)
|
0.70
(0.73)
|
0.47
(0.70)
|
1.11
(0.78)
|
| Visit 3 |
0.59
(0.62)
|
0.22
(0.43)
|
0.67
(1.21)
|
1.00
(0.97)
|
0.36
(0.68)
|
0.67
(0.52)
|
| Visit 4 |
0.58
(0.79)
|
0.61
(0.70)
|
0.75
(0.50)
|
0.62
(0.65)
|
0.72
(0.89)
|
1.20
(0.84)
|
| Title | Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Visit 1 |
0.33
(0.84)
|
0.33
(0.80)
|
1.33
(3.64)
|
0.05
(0.22)
|
0.22
(0.54)
|
0.10
(0.32)
|
| Visit 2 |
0.41
(0.51)
|
0.63
(0.76)
|
0.50
(0.76)
|
0.65
(0.93)
|
0.64
(0.96)
|
0.22
(0.44)
|
| Visit 3 |
0.29
(0.47)
|
0.17
(0.38)
|
1.00
(1.26)
|
0.25
(0.45)
|
0.33
(0.59)
|
0.33
(0.52)
|
| Visit 4 |
0.42
(0.67)
|
0.56
(0.86)
|
1.50
(1.29)
|
0.46
(0.78)
|
0.38
(0.75)
|
1.40
(2.07)
|
| Title | Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 21 | 36 | 10 |
| Visit 1 |
13
72.2%
|
28
133.3%
|
7
77.8%
|
| Visit 2 |
16
88.9%
|
23
109.5%
|
8
88.9%
|
| Visit 3 |
12
66.7%
|
24
114.3%
|
3
33.3%
|
| Visit 4 |
11
61.1%
|
23
109.5%
|
3
33.3%
|
| Title | Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 |
| Visit 1 |
1
5.6%
|
15
71.4%
|
1
11.1%
|
| Visit 2 |
14
77.8%
|
16
76.2%
|
4
44.4%
|
| Visit 3 |
12
66.7%
|
14
66.7%
|
3
33.3%
|
| Visit 4 |
10
55.6%
|
16
76.2%
|
1
11.1%
|
| Title | Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 21 | 36 | 10 |
| Visit 1 |
0
0%
|
0
0%
|
0
0%
|
| Visit 2 |
4
22.2%
|
3
14.3%
|
3
33.3%
|
| Visit 3 |
5
27.8%
|
4
19%
|
2
22.2%
|
| Visit 4 |
4
22.2%
|
2
9.5%
|
1
11.1%
|
| Title | Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 |
| Visit 1 |
0
0%
|
0
0%
|
0
0%
|
| Visit 2 |
12
66.7%
|
2
9.5%
|
4
44.4%
|
| Visit 3 |
13
72.2%
|
2
9.5%
|
3
33.3%
|
| Visit 4 |
8
44.4%
|
2
9.5%
|
2
22.2%
|
| Title | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
17.52
(3.13)
|
4.96
(2.2)
|
NA
(NA)
|
6.73
(2.34)
|
-0.19
(1.19)
|
12.72
(6.19)
|
| Change at Visit 3 |
21.23
(3.48)
|
6.4
(1.97)
|
NA
(NA)
|
7.71
(2.88)
|
0.46
(1.22)
|
11.97
(5.41)
|
| Change at Visit 4 |
23.57
(3.9)
|
8.29
(2.6)
|
NA
(NA)
|
9.7
(2.62)
|
0.86
(1.75)
|
11.7
(1.57)
|
| Title | Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Change at Visit 2 |
16.68
(4.12)
|
2.31
(2.41)
|
NA
(NA)
|
6.16
(5.97)
|
0.67
(2.79)
|
6.83
(6.52)
|
| Change at Visit 3 |
17.93
(4.28)
|
6.49
(2.23)
|
NA
(NA)
|
6.75
(5.88)
|
0.23
(2.38)
|
4.89
(7.44)
|
| Change at Visit 4 |
13.6
(5.25)
|
9.88
(3.31)
|
NA
(NA)
|
13.56
(6.11)
|
1.75
(1.74)
|
1.22
(12.63)
|
| Title | Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 |
| E1 Ulcerative proctitis |
3
16.7%
|
1
4.8%
|
1
11.1%
|
| E2 Left-sided UC |
6
33.3%
|
3
14.3%
|
4
44.4%
|
| E3 Extensive UC |
8
44.4%
|
16
76.2%
|
4
44.4%
|
| Unknown |
1
5.6%
|
1
4.8%
|
0
0%
|
| Title | Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 21 | 36 | 10 |
| Location: L1 Terminal ileum |
7
38.9%
|
12
57.1%
|
3
33.3%
|
| Location: L2 Colon |
6
33.3%
|
12
57.1%
|
4
44.4%
|
| Location: L3 Ileocolon |
8
44.4%
|
7
33.3%
|
3
33.3%
|
| Location: L4 Upper GI |
0
0%
|
1
4.8%
|
0
0%
|
| Location: Unknown |
0
0%
|
4
19%
|
0
0%
|
| Behavior: B1 Nonstricturing, nonpenetrating |
11
61.1%
|
3
14.3%
|
6
66.7%
|
| Behavior: B2 Stricturing |
4
22.2%
|
6
28.6%
|
1
11.1%
|
| Behavior: B3 Penetrating |
4
22.2%
|
0
0%
|
1
11.1%
|
| Behavior: P Perianal disease |
0
0%
|
2
9.5%
|
1
11.1%
|
| Behavior: Unknown |
2
11.1%
|
25
119%
|
1
11.1%
|
| Title | Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 |
| Mean (Standard Deviation) [units on a scale] |
5.67
(2.25)
|
1.38
(1.83)
|
6.00
(2.65)
|
| Title | Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 21 | 36 | 10 |
| Mean (Standard Deviation) [units on a scale] |
3.95
(3.15)
|
3.11
(3.05)
|
3.57
(2.51)
|
| Title | Number of Participants With Infections |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who signed an informed consent. |
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| All Infections |
0
0%
|
1
4.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serious Infections |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Malignancy and Lymphoma |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who signed an informed consent. |
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Malignancy and Lymphoma (Serious Adverse Event) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
8.3%
|
0
0%
|
| Malignancy and Lymphoma (Non-serious Adverse Event) |
0
0%
|
0
0%
|
0
0%
|
1
4.8%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Infusion-related Reactions |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who signed an informed consent. |
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Infusion-related reactions (serious adverse event) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Infusion-related reactions (non-serious adverse event) |
1
5.6%
|
1
4.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Any Serious Adverse Event |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who signed an informed consent. |
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Count of Participants [Participants] |
0
0%
|
3
14.3%
|
1
11.1%
|
5
23.8%
|
8
22.2%
|
2
20%
|
| Title | Duration of Inflectra Therapy |
|---|---|
| Description | In this outcome measure duration of Inflectra treatment (in months) is reported. |
| Time Frame | Visit 1 to 4 (approximately 1 year) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 35 | 10 |
| Mean (Standard Deviation) [months] |
11.13
(3.71)
|
10.42
(3.67)
|
8.90
(4.40)
|
10.37
(3.22)
|
11.83
(2.27)
|
9.59
(3.70)
|
| Title | Number of Participants With Any Changes in Dosing |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category. |
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Visit 1 |
3
16.7%
|
5
23.8%
|
0
0%
|
1
4.8%
|
7
19.4%
|
1
10%
|
| Visit 2 |
6
33.3%
|
4
19%
|
4
44.4%
|
10
47.6%
|
1
2.8%
|
4
40%
|
| Visit 3 |
5
27.8%
|
2
9.5%
|
2
22.2%
|
3
14.3%
|
3
8.3%
|
1
10%
|
| Visit 4 |
3
16.7%
|
2
9.5%
|
1
11.1%
|
6
28.6%
|
4
11.1%
|
2
20%
|
| Title | Number of Participants Who Completed Each Study Visit |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category. |
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 18 | 21 | 9 | 21 | 36 | 10 |
| Visit 1 |
18
100%
|
21
100%
|
9
100%
|
21
100%
|
36
100%
|
10
100%
|
| Visit 2 |
17
94.4%
|
19
90.5%
|
8
88.9%
|
20
95.2%
|
36
100%
|
9
90%
|
| Visit 3 |
17
94.4%
|
18
85.7%
|
6
66.7%
|
16
76.2%
|
36
100%
|
6
60%
|
| Visit 4 |
12
66.7%
|
18
85.7%
|
4
44.4%
|
13
61.9%
|
32
88.9%
|
5
50%
|
Adverse Events
| Time Frame | Visit 1 to 4 (approximately 1 year) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set. | |||||||||||
| Arm/Group Title | UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics | ||||||
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | ||||||
All Cause Mortality |
||||||||||||
| UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 3/21 (14.3%) | 1/9 (11.1%) | 5/21 (23.8%) | 8/36 (22.2%) | 2/10 (20%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Abdominal abscess | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Anal fissure | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 1/10 (10%) | ||||||
| Colitis | 0/18 (0%) | 1/21 (4.8%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Colon stenosis | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 1/10 (10%) | ||||||
| Colovesical fistula | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Crohn's disease | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 2/10 (20%) | ||||||
| Small bowel obstruction | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 1/10 (10%) | ||||||
| General disorders | ||||||||||||
| Drug ineffective | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 2/36 (5.6%) | 0/10 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Liver abscess | 0/18 (0%) | 0/21 (0%) | 1/9 (11.1%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Investigations | ||||||||||||
| Drug specific antibody present | 0/18 (0%) | 1/21 (4.8%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Osteoarthritis | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Pancreatic carcinoma | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Squamous cell carcinoma of lung | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Squamous cell carcinoma of skin | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||
| Abortion spontaneous | 0/18 (0%) | 1/21 (4.8%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Near syncope during pregnancy | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Bronchitis | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Pneumonia | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| UC: New Inflectra | UC: Inflectra After Remicade | UC: Inflectra After Other Biologics | CD: New Inflectra | CD: Inflectra After Remicade | CD: Inflectra After Other Biologics | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/18 (11.1%) | 4/21 (19%) | 5/9 (55.6%) | 6/21 (28.6%) | 7/36 (19.4%) | 3/10 (30%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Thrombosis | 0/18 (0%) | 0/21 (0%) | 2/9 (22.2%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Abdominal discomfort | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Colitis ulcerative aggravated | 0/18 (0%) | 0/21 (0%) | 1/9 (11.1%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Disease recurrence | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Perianal abscess | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| General disorders | ||||||||||||
| Drug ineffective | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Fatigue | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Infusion related reaction | 1/18 (5.6%) | 1/21 (4.8%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Injection site bruising | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Malaise | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Hepatic enzymes increased | 0/18 (0%) | 1/21 (4.8%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Immune system disorders | ||||||||||||
| Hypersensitivity | 0/18 (0%) | 1/21 (4.8%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 1/10 (10%) | ||||||
| Infections and infestations | ||||||||||||
| Staphylococcal infection | 0/18 (0%) | 1/21 (4.8%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Exposure during pregnancy | 0/18 (0%) | 0/21 (0%) | 1/9 (11.1%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 1/18 (5.6%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 1/10 (10%) | ||||||
| Lupus-like syndrome | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Osteoporosis/osteopenia | 0/18 (0%) | 0/21 (0%) | 1/9 (11.1%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Pain in extremity | 0/18 (0%) | 0/21 (0%) | 1/9 (11.1%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Low-grade B cell lymphoma | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Bronchitis | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Cough | 1/18 (5.6%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Influenza | 0/18 (0%) | 0/21 (0%) | 1/9 (11.1%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Nasopharyngitis | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 1/36 (2.8%) | 0/10 (0%) | ||||||
| Pneumonia | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Sinusitis | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 2/36 (5.6%) | 0/10 (0%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Dermatitis psoriasiform | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 1/21 (4.8%) | 0/36 (0%) | 1/10 (10%) | ||||||
| Eczema | 0/18 (0%) | 0/21 (0%) | 1/9 (11.1%) | 0/21 (0%) | 0/36 (0%) | 0/10 (0%) | ||||||
| Hidradenitis | 0/18 (0%) | 0/21 (0%) | 0/9 (0%) | 0/21 (0%) | 0/36 (0%) | 1/10 (10%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03801928
Other Study ID Numbers:
- C1231006
- ONWARD
First Posted:
Jan 14, 2019
Last Update Posted:
Mar 2, 2021
Last Verified:
Feb 1, 2021