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    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

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    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

    Subject disposition

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    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.

    Number of subjects in period 1
    Subjects Receiving Adalimumab
    Started
    463
    Completed
    353
    Not completed
    110
         Lack of efficacy
    59
         Consent withdrawn by subject
    10
         Adverse Event
    26
         Not Specified
    13
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    463 463
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.8 ± 13.72 -
    Gender categorical
    Units: Subjects
        Female
    207 207
        Male
    256 256

    End points

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    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.

    Primary: Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score

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    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).
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    460 [2]
    Units: units on a scale
        arithmetic mean (standard deviation)
    17.4 ± 14.48
    Notes
    [2] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Primary: 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

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    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).
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    461 [4]
    Units: Pound Sterling (GBP)
        arithmetic mean (standard deviation)
    -1383.8 ± 2213.06
    Notes
    [4] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: 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)

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    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)
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    461 [5]
    Units: Pound Sterling (GBP)
        arithmetic mean (standard deviation)
    -1297.8 ± 2888.89
    Notes
    [5] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: 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

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    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)
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    461 [6]
    Units: Pound Sterling (GBP)
        arithmetic mean (standard deviation)
    -4308.3 ± 7394.75
    Notes
    [6] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: 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

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    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)
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    158 [7]
    Units: Days
        arithmetic mean (standard deviation)
    -7.3 ± 16.06
    Notes
    [7] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Subject's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    449 [8]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        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
    Notes
    [8] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: 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

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    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)
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    453 [9]
    Units: Procedures/ Surgeries
    arithmetic mean (standard deviation)
        Overall
    -4.8 ± 6.25
        During emergency department visits
    0 ± 1.09
        During primary care doctor visits
    -0.9 ± 2.82
    Notes
    [9] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Absence of Blood in Stool

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    461 [10]
    Units: Percentage of Participants
        number (not applicable)
    56.6
    Notes
    [10] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    460 [11]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        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
    Notes
    [11] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Physician's Global Assessment (PGA)

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    461 [12]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.6 ± 0.69
        Week 8
    -1.1 ± 0.85
        Week 18
    -0.9 ± 0.95
        Week 26
    -1.1 ± 0.97
    Notes
    [12] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    461 [13]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 2
    -3.2 ± 2.55
        Week 8
    -4.1 ± 3.33
        Week 18
    -3 ± 3.79
        Week 26
    -4.1 ± 3.88
    Notes
    [13] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in European Quality of Life – 5 Dimensions – 5 Level (EQ-5D-5L) Total Score

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    454 [14]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        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
    Notes
    [14] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    227 [15]
    Units: Percentage of work time missed
    arithmetic mean (standard deviation)
        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
    Notes
    [15] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    234 [16]
    Units: Percentage of impairment while working
    arithmetic mean (standard deviation)
        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
    Notes
    [16] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    225 [17]
    Units: Percentage of overall work impairment
    arithmetic mean (standard deviation)
        Week 2 (N= 211)
    -18.3 ± 27.72
        Week 8 (N= 225)
    -26.5 ± 34.56
        Week 18 (N= 223)
    -25.3 ± 35.1
        Week 26 (N= 221)
    -29.2 ± 32.32
    Notes
    [17] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment

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    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
    End point values
    Subjects Receiving Adalimumab
    Number of subjects analysed
    446 [18]
    Units: Percentage of activity impairment
    arithmetic mean (standard deviation)
        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
    Notes
    [18] - All subjects in the ITT population with evaluable data.
    No statistical analyses for this end point

    Adverse events

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    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.

    Serious adverse events
    Subjects Receiving Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    67 / 463 (14.47%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    2 / 463 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma of eyelid
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Testicular seminoma (pure)
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Foetal death
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Foetal distress syndrome
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Asthenia
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Silent myocardial infarction
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 463 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracranial venous sinus thrombosis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    41 / 463 (8.86%)
         occurrences causally related to treatment / all
    1 / 46
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatosis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pruritus generalised
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteitis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound sepsis
         subjects affected / exposed
    1 / 463 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Subjects Receiving Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    178 / 463 (38.44%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    27 / 463 (5.83%)
         occurrences all number
    30
    Oropharyngeal pain
         subjects affected / exposed
    25 / 463 (5.40%)
         occurrences all number
    27
    Nervous system disorders
    Headache
         subjects affected / exposed
    60 / 463 (12.96%)
         occurrences all number
    112
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    61 / 463 (13.17%)
         occurrences all number
    72
    Nausea
         subjects affected / exposed
    29 / 463 (6.26%)
         occurrences all number
    34
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    33 / 463 (7.13%)
         occurrences all number
    34
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    37 / 463 (7.99%)
         occurrences all number
    46

    More information

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    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
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