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A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting (InspirAda)

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ClinicalTrials.gov Identifier: NCT01550965
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : November 1, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Intervention Biological: Adalimumab
Enrollment 463

Recruitment Details  
Pre-assignment Details A total of 463 participants were enrolled: 461 in the intent to treat (ITT) population were analyzed for efficacy (excluding 2 due to lack of post-baseline measurement data); 463 were analyzed for safety (participants who had received at least one dose of study drug).
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description Adults with active ulcerative colitis (UC) who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Period Title: Overall Study
Started 463
Completed 353
Not Completed 110
Reason Not Completed
Adverse Event             26
Withdrawal by Subject             10
Lost to Follow-up             2
Lack of Efficacy             59
Not Specified             13
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Baseline Participants 461
Hide Baseline Analysis Population Description
Intention to Treat (ITT) population: all participants who had received at least one dose of study drug and had data for at least one post-baseline assessment of any effectiveness measurement [up to and including Week 26] while receiving treatment with adalimumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 461 participants
41.8  (13.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 461 participants
Female
206
  44.7%
Male
255
  55.3%
1.Primary Outcome
Title Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score
Hide Description The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).
Time Frame Week 0 (baseline) and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 460
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.4  (14.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.40
Confidence Interval (2-Sided) 95%
16.08 to 18.73
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs
Hide Description Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.
Time Frame 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 461
Mean (Standard Deviation)
Unit of Measure: Pound Sterling (GBP)
-1383.8  (2213.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1383.81
Confidence Interval (2-Sided) 95%
-1586.36 to -1181.26
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)
Hide Description Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.
Time Frame 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 461
Mean (Standard Deviation)
Unit of Measure: Pound Sterling (GBP)
-1297.8  (2888.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1297.77
Confidence Interval (2-Sided) 95%
-1562.17 to -1033.36
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs
Hide Description UC-related direct and indirect health care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments, medications and indirect costs based on WPAI.
Time Frame 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 461
Mean (Standard Deviation)
Unit of Measure: Pound Sterling (GBP)
-4308.3  (7394.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4308.32
Confidence Interval (2-Sided) 95%
-4985.13 to -3631.51
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization
Hide Description Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.
Time Frame 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 158
Mean (Standard Deviation)
Unit of Measure: Days
-7.3  (16.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.3
Confidence Interval (2-Sided) 95%
-9.83 to -4.78
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)
Hide Description TSQM is a questionnaire to be completed by the participants to determine their satisfaction of the medications for ulcerative colitis including the study drug. The TSQM is a 14-item subject-rated scale that evaluates the effectiveness, side effects, convenience, and global satisfaction of the medication over the past 2-3 weeks. Each of the 14 questions are scored from 1 (worst) to 7 points (best); and each of the domains are scored from 0 (less satisfaction) to 100 (better satisfaction). N = participants with evaluable baseline and post-baseline data.
Time Frame Week 0 (baseline) and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 452
Mean (Standard Deviation)
Unit of Measure: units on a scale
Effectiveness (N=452) 24.4  (31.09)
Side Effects (N=449) 18.9  (38.06)
Convenience (N=451) 6.2  (24.87)
Global Satisfaction (N=449) 22.6  (32.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 24.37
Confidence Interval (2-Sided) 95%
21.50 to 27.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.95
Confidence Interval (2-Sided) 95%
15.42 to 22.48
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.20
Confidence Interval (2-Sided) 95%
3.89 to 8.50
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.60
Confidence Interval (2-Sided) 95%
19.55 to 25.64
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures
Hide Description UC-related outpatient utilization was determined from the health care utilization information. Outpatient utilization was the number of procedures/surgeries performed during outpatient visits. Participants without any outpatient utilization were excluded.
Time Frame 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 453
Mean (Standard Deviation)
Unit of Measure: Procedures/ Surgeries
Overall -4.8  (6.25)
During emergency department visits 0.0  (1.09)
During primary care doctor visits -0.9  (2.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for overall UC-related outpatient utilization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.85
Confidence Interval (2-Sided) 95%
-5.42 to -4.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for overall UC-related outpatient utilization during emergency department visits.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.830
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.11 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.18 to -0.66
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Absence of Blood in Stool
Hide Description Participants with absence of blood in stool were reported.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 461
Measure Type: Number
Unit of Measure: percentage of participants
56.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time
Hide Description The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). N = participants with evaluable baseline and post-baseline data.
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 460
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (N=457) 11.1  (9.81)
Week 8 (N=459) 15.4  (12.83)
Week 18 (N=459) 14.8  (13.06)
Week 26 (N=460) 17.4  (14.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.11
Confidence Interval (2-Sided) 95%
10.21 to 12.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.38
Confidence Interval (2-Sided) 95%
14.20 to 16.56
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.77
Confidence Interval (2-Sided) 95%
13.57 to 15.96
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.40
Confidence Interval (2-Sided) 95%
16.08 to 18.73
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline in Physician's Global Assessment (PGA)
Hide Description The Physician’s Global Assessment was used to measure the participant’s disease activity. The physician considered the participant’s reported information such as number of stools, rectal bleeding, abdominal discomfort, and functional assessment during the previous day prior to the visit, and other observations such as physical findings, and the participant’s performance status at the time of the visit. Based on the above information the investigator made an overall assessment of participant’s current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease).
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 461
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -0.6  (0.69)
Week 8 -1.1  (0.85)
Week 18 -0.9  (0.95)
Week 26 -1.1  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in PGA from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-0.69 to -0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in PGA from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-1.16 to -1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-0.95 to -0.77
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in PGA from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-1.23 to -1.06
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)
Hide Description The SCCAI measures disease activity as assessed by the investigator and includes the following 6 items: bowel frequency (day), bowel frequency (night), urgency of defecation, blood in stool, general well-being and extra colonic features. The score ranges from 0 (best) to 19 points (worst).
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 461
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -3.2  (2.55)
Week 8 -4.1  (3.33)
Week 18 -3.0  (3.79)
Week 26 -4.1  (3.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total SCCAI from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.22
Confidence Interval (2-Sided) 95%
-3.46 to -2.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total SCCAI from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.06
Confidence Interval (2-Sided) 95%
-4.37 to -3.76
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.01
Confidence Interval (2-Sided) 95%
-3.36 to -2.66
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total SCCAI from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.07
Confidence Interval (2-Sided) 95%
-4.43 to -3.72
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Change From Baseline in European Quality of Life – 5 Dimensions – 5 Level (EQ-5D-5L) Total Score
Hide Description EQ-5D-5L Total Score provides a descriptive profile of health status. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems). A unique EQ-5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from -0.594 to 1, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. N = participants with evaluable baseline and post-baseline data.
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 454
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (N=452) 0.1  (0.18)
Week 8 (N=454) 0.1  (0.21)
Week 18 (N=454) 0.1  (0.22)
Week 26 (N=454) 0.1  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.08 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
0.11 to 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.10 to 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
0.12 to 0.17
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed
Hide Description WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of work time missed data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:

Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.

Adalimumab: Adalimumab pre-filled syringe, administered by subcutaneous injection

Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: percentage of work time missed
Week 2 (N=214) -8.6  (25.55)
Week 8 (N=227) -12.2  (30.97)
Week 18 (N=225) -11.6  (32.04)
Week 26 (N=223) -11.4  (30.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.62
Confidence Interval (2-Sided) 95%
-12.07 to -5.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.22
Confidence Interval (2-Sided) 95%
-16.27 to -8.16
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.61
Confidence Interval (2-Sided) 95%
-15.82 to -7.40
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.43
Confidence Interval (2-Sided) 95%
-15.50 to -7.35
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working
Hide Description WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of impairment while working data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 234
Mean (Standard Deviation)
Unit of Measure: percentage of impairment while working
Week 2 (N=221) -16.6  (25.94)
Week 8 (N=234) -22.9  (30.91)
Week 18 (N=232) -21.7  (30.98)
Week 26 (N=229) -24.5  (29.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.56
Confidence Interval (2-Sided) 95%
-20.00 to -13.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.95
Confidence Interval (2-Sided) 95%
-26.93 to -18.97
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.68
Confidence Interval (2-Sided) 95%
-25.69 to -17.67
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.45
Confidence Interval (2-Sided) 95%
-28.33 to -20.58
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage
Hide Description WPAI-SHP is a questionnaire used to assess the effect of the participant’s health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The overall work impairment data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 225
Mean (Standard Deviation)
Unit of Measure: percentage of overall work impairment
Week 2 (N= 211) -18.3  (27.72)
Week 8 (N= 225) -26.5  (34.56)
Week 18 (N= 223) -25.3  (35.10)
Week 26 (N= 221) -29.2  (32.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.34
Confidence Interval (2-Sided) 95%
-22.10 to -14.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -26.54
Confidence Interval (2-Sided) 95%
-31.08 to -22.00
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.33
Confidence Interval (2-Sided) 95%
-29.97 to -20.70
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.22
Confidence Interval (2-Sided) 95%
-33.50 to -24.93
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment
Hide Description WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. N = participants with evaluable baseline and post-baseline data.
Time Frame Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Participants Receiving Adalimumab
Hide Arm/Group Description:
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Overall Number of Participants Analyzed 446
Mean (Standard Deviation)
Unit of Measure: percentage of activity impairment
Week 2 (N=435) -18.2  (24.55)
Week 8 (N=446) -25.4  (30.84)
Week 18 (N=446) -24.4  (31.35)
Week 26 (N-446) -27.2  (32.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.16
Confidence Interval (2-Sided) 95%
-20.47 to -15.85
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.43
Confidence Interval (2-Sided) 95%
-28.30 to -22.56
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.42
Confidence Interval (2-Sided) 95%
-27.33 to -21.50
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants Receiving Adalimumab
Comments Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.22
Confidence Interval (2-Sided) 95%
-30.28 to -24.16
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks).
Adverse Event Reporting Description Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
 
Arm/Group Title PARTICIPANTS RECEIVING ADALIMUMAB
Hide Arm/Group Description Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
All-Cause Mortality
PARTICIPANTS RECEIVING ADALIMUMAB
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PARTICIPANTS RECEIVING ADALIMUMAB
Affected / at Risk (%)
Total   67/463 (14.47%) 
Blood and lymphatic system disorders   
ANAEMIA  1  2/463 (0.43%) 
PANCYTOPENIA  1  1/463 (0.22%) 
THROMBOCYTOPENIA  1  1/463 (0.22%) 
Cardiac disorders   
SILENT MYOCARDIAL INFARCTION  1  1/463 (0.22%) 
Endocrine disorders   
HYPERTHYROIDISM  1  1/463 (0.22%) 
Gastrointestinal disorders   
ABDOMINAL PAIN LOWER  1  1/463 (0.22%) 
COLITIS ULCERATIVE  1  41/463 (8.86%) 
DIARRHOEA  1  1/463 (0.22%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/463 (0.22%) 
MEGACOLON  1  1/463 (0.22%) 
General disorders   
ACCIDENTAL DEATH  1  1/463 (0.22%) 
ASTHENIA  1  1/463 (0.22%) 
Infections and infestations   
APPENDICITIS  1  1/463 (0.22%) 
CELLULITIS  1  1/463 (0.22%) 
CYTOMEGALOVIRUS INFECTION  1  1/463 (0.22%) 
GASTROENTERITIS  1  1/463 (0.22%) 
HERPES ZOSTER  1  1/463 (0.22%) 
OSTEOMYELITIS  1  1/463 (0.22%) 
OTITIS MEDIA  1  1/463 (0.22%) 
PYELONEPHRITIS  1  1/463 (0.22%) 
RECTAL ABSCESS  1  1/463 (0.22%) 
SINUSITIS  1  1/463 (0.22%) 
WOUND SEPSIS  1  1/463 (0.22%) 
Injury, poisoning and procedural complications   
ANKLE FRACTURE  1  1/463 (0.22%) 
PNEUMOTHORAX TRAUMATIC  1  1/463 (0.22%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  1/463 (0.22%) 
OSTEITIS  1  1/463 (0.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
MALIGNANT MELANOMA OF EYELID  1  1/463 (0.22%) 
PROSTATE CANCER  1  1/463 (0.22%) 
TESTICULAR SEMINOMA (PURE)  1  1/463 (0.22%) 
Nervous system disorders   
CEREBRAL HAEMORRHAGE  1  1/463 (0.22%) 
DIZZINESS  1  1/463 (0.22%) 
INTRACRANIAL VENOUS SINUS THROMBOSIS  1  1/463 (0.22%) 
Pregnancy, puerperium and perinatal conditions   
FOETAL DEATH  1  1/463 (0.22%) 
FOETAL DISTRESS SYNDROME  1  1/463 (0.22%) 
Psychiatric disorders   
DEPRESSION  1  1/463 (0.22%) 
Skin and subcutaneous tissue disorders   
DERMATOSIS  1  1/463 (0.22%) 
PRURITUS GENERALISED  1  1/463 (0.22%) 
Surgical and medical procedures   
ABORTION INDUCED  1  2/463 (0.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PARTICIPANTS RECEIVING ADALIMUMAB
Affected / at Risk (%)
Total   178/463 (38.44%) 
Gastrointestinal disorders   
COLITIS ULCERATIVE  1  61/463 (13.17%) 
NAUSEA  1  29/463 (6.26%) 
Infections and infestations   
NASOPHARYNGITIS  1  37/463 (7.99%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  33/463 (7.13%) 
Nervous system disorders   
HEADACHE  1  60/463 (12.96%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  27/463 (5.83%) 
OROPHARYNGEAL PAIN  1  25/463 (5.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Information
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01550965     History of Changes
Other Study ID Numbers: M13-045
2011-002411-29 ( EudraCT Number )
First Submitted: March 8, 2012
First Posted: March 12, 2012
Results First Submitted: April 1, 2016
Results First Posted: November 1, 2016
Last Update Posted: July 2, 2018