Clinical Trial Results:
An Open-Label Multicenter 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
|
Summary
|
|
EudraCT number |
2011-002411-29 |
Trial protocol |
SE ES GB DE BE DK GR PT AT IE IT FI CZ SK PL |
Global end of trial date |
28 May 2015
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
07 May 2016
|
First version publication date |
07 May 2016
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
M13-045
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01550965 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
AbbVie Deutschland GmbH & Co. KG
|
||
Sponsor organisation address |
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
|
||
Public contact |
Global Medical Information, AbbVie, 001 800-633-9110,
|
||
Scientific contact |
John Medich, AbbVie, john.medich@abbvie.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
28 May 2015
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
28 May 2015
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in subjects with ulcerative colitis (UC).
|
||
Protection of trial subjects |
All subjects entering the study had to sign an informed consent that was explained to them and questions encouraged.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 May 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Poland: 24
|
||
Country: Number of subjects enrolled |
Portugal: 4
|
||
Country: Number of subjects enrolled |
Slovakia: 10
|
||
Country: Number of subjects enrolled |
Spain: 24
|
||
Country: Number of subjects enrolled |
Sweden: 2
|
||
Country: Number of subjects enrolled |
United Kingdom: 90
|
||
Country: Number of subjects enrolled |
Austria: 5
|
||
Country: Number of subjects enrolled |
Belgium: 29
|
||
Country: Number of subjects enrolled |
Czech Republic: 3
|
||
Country: Number of subjects enrolled |
Denmark: 11
|
||
Country: Number of subjects enrolled |
France: 31
|
||
Country: Number of subjects enrolled |
Germany: 14
|
||
Country: Number of subjects enrolled |
Greece: 8
|
||
Country: Number of subjects enrolled |
Ireland: 14
|
||
Country: Number of subjects enrolled |
Italy: 49
|
||
Country: Number of subjects enrolled |
Canada: 53
|
||
Country: Number of subjects enrolled |
Israel: 27
|
||
Country: Number of subjects enrolled |
Russian Federation: 50
|
||
Country: Number of subjects enrolled |
Switzerland: 3
|
||
Country: Number of subjects enrolled |
Turkey: 12
|
||
Worldwide total number of subjects |
463
|
||
EEA total number of subjects |
318
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
432
|
||
From 65 to 84 years |
31
|
||
85 years and over |
0
|
||
|
|||||||||||||||||||
|
Recruitment
|
|||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||||
Screening details |
A total of 463 subjects 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 (subjects who had received at least one dose of study drug). | ||||||||||||||||||
|
Period 1
|
|||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||
|
Arms
|
|||||||||||||||||||
|
Arm title
|
Subjects Receiving Adalimumab | ||||||||||||||||||
Arm 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 nonresponse. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Adalimumab
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
ABT-D2E7, Humira
|
||||||||||||||||||
Pharmaceutical forms |
Solution for injection
|
||||||||||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||||||||||
Dosage and administration details |
Adalimumab pre-filled syringe, administered by subcutaneous injection.
|
||||||||||||||||||
|
|||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||
Reporting group title |
Overall Study
|
|||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Subjects Receiving Adalimumab
|
||
Reporting 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 nonresponse. | ||
|
|||||||||
End point title |
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score [1] | ||||||||
End point 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) subjects 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).
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Week 0 (baseline) and Week 26
|
||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: 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. The mean difference (95% CI) from baseline to week 26 was 17.40 (16.08 to 18.73) (P<0.001). |
|||||||||
|
|||||||||
| Notes [2] - All subjects in the ITT population with evaluable data. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point 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 [3] | ||||||||
End point 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
|
||||||||
| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: 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. The mean difference (95% CI) from 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) was -1383.81 (-1586.36 to -1181.26) (P<0.001). |
|||||||||
|
|||||||||
| Notes [4] - All subjects in the ITT population with evaluable data. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point 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) | ||||||||
End point 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.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
|
||||||||
|
|||||||||
| Notes [5] - All subjects in the ITT population with evaluable data. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point 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 | ||||||||
End point 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.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
|
||||||||
|
|||||||||
| Notes [6] - All subjects in the ITT population with evaluable data. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point 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 | ||||||||
End point description |
Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
|
||||||||
|
|||||||||
| Notes [7] - All subjects in the ITT population with evaluable data. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Subject's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM) | ||||||||||||||||
End point description |
TSQM is a questionnaire to be completed by the subjects 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 question is scored from 1 (worst) to 7 points (best); total scores range from 0 to 100 (higher score indicates better satisfaction). N = subjects with evaluable baseline and post-baseline data.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline) and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [8] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||
End point 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 | ||||||||||||||
End point 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. Subjects without any outpatient utilization were excluded.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
|
||||||||||||||
|
|||||||||||||||
| Notes [9] - All subjects in the ITT population with evaluable data. |
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||
End point title |
Percentage of Subjects With Absence of Blood in Stool | ||||||||
End point description |
Subjects with absence of blood in stool were reported.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 26
|
||||||||
|
|||||||||
| Notes [10] - All subjects in the ITT population with evaluable data. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time | ||||||||||||||||
End point description |
The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) subjects 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). Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF). N = subjects with evaluable baseline and post-baseline data.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [11] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Physician's Global Assessment (PGA) | ||||||||||||||||
End point description |
The Physician's Global Assessment was used to measure the subject's disease activity. The physician considered the subject'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 subject's performance status at the time of the visit. Based on the above information the investigator made an overall assessment of subject's current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease). Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [12] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) | ||||||||||||||||
End point 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). Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [13] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in European Quality of Life – 5 Dimensions – 5 Level (EQ-5D-5L) Total Score | ||||||||||||||||
End point 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. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF). N = subjects with evaluable baseline and post-baseline data.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [14] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed | ||||||||||||||||
End point description |
WPAI-SHP is a questionnaire used to assess the effect of the subject'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 subjects only. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF). N = subjects with evaluable baseline and post-baseline data.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [15] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working | ||||||||||||||||
End point description |
WPAI-SHP is a questionnaire used to assess the effect of the subject'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 impairment while working data was applicable to employed subjects only. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF). N = subjects with evaluable baseline and post-baseline data.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [16] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage | ||||||||||||||||
End point description |
WPAI-SHP is a questionnaire used to assess the effect of the subject'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 overall work impairment data was applicable to employed subjects only. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF). N = subjects with evaluable baseline and post-baseline data.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [17] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment | ||||||||||||||||
End point description |
WPAI-SHP is a questionnaire used to assess the effect of the subject'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. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF). N = subjects with evaluable baseline and post-baseline data.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
|
||||||||||||||||
|
|||||||||||||||||
| Notes [18] - All subjects in the ITT population with evaluable data. |
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
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 additional 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).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Subjects Receiving Adalimumab
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
19 Sep 2011 |
The purpose of this amendment was to add visit windows, extend the Screening period to allow for receipt of test results, add enrollment fulfillment statement, and clarified description of study design and study drug discontinuation; inclusion and exclusion criteria were updated; corrected efficacy variable description, revised the secondary variables to accurately define the secondary endpoints, and deleted ECG and CXR from safety variables; updated statistical analyses of efficacy, statistical analyses of safety, and other analyses with corrected and consolidated description of the analyses; and updated recording of previous medications to within 6 months prior to Week 0 (baseline) and provided direction on concomitant medication recording. |
||
05 Apr 2012 |
The purpose of this amendment was to add week 18 visit and the week 18 study window; added the criterion for non-response at week 8 per country requirements; changed the starting week for dose escalation to be consistent with the proposed label; changed the age requirements to ensure that the subjects were at least 18 years old at the time the informed consent was signed; and exclusion criteria were clarified, added and revised. |
||
28 Feb 2013 |
The purpose of the amendment was to change the effectiveness endpoint "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" from a secondary effectiveness endpoint to the second ranked primary effectiveness endpoint; revised the number of subjects to be enrolled in the study due to recalculation of sample size based on change of primary effectiveness endpoints and increased the number of sites in order to facilitate enrollment; extended the screening period for initiation of prophylactic anti-TB therapy and for repeat screening procedure(s) or laboratory test(s); and removed the wording of previous treatment with an anti-TNF agent including infliximab as an exclusion criterion and modified to indicate that the study design would enroll approximately 30% of anti-TNF experienced subjects. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
