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For public health purposes disability is becoming increasingly important as an outcome measure. Despite this, there are few data on the effectiveness of adalimumab on disability outcomes in patients with immune-mediated inflammatory diseases (IMIDs), particularly in the Phase IV setting. There are even less data available in New Zealand, which did not have the opportunity to participate to a major extent in large, multinational, Phase III pivotal studies of adalimumab in IMIDs.
The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple, validated, free and easy-to-use generic assessment instrument for health and disability. It is applicable across cultures, in all adult populations. It is a responsive measure that can show what difference a treatment makes.
Results from study of effect of adalimumab on WHODAS scores and other patient-reported outcomes (PROs) of work activity and well-being will be of interest to a variety of stakeholders in the healthcare system including patients, healthcare practitioners and payers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn's Disease | Participants with Crohn's disease. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. | ||
| Rheumatoid Arthritis | Participants with rheumatoid arthritis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. | ||
| Psoriasis | Participants with psoriasis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be males and/or females who are attending a routine clinical visit and meet all of the inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31233347 | Derived | Gearry RB, Frampton C, Inns S, Poppelwell D, Rademaker M, Suppiah R. VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand. Curr Med Res Opin. 2019 Oct;35(10):1837-1846. doi: 10.1080/03007995.2019.1634952. Epub 2019 Jul 3. |
| Label | URL |
|---|---|
| http://rxabbvie.com/ | View source |
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Of the 168 recruited participants, 4 withdrew or were withdrawn prior to baseline measures being completed (164 participants had baseline World Health Organization Disability Assessment Schedule [WHODAS] data recorded).
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| ID | Title | Description |
|---|---|---|
| FG000 | Crohn's Disease | Participants with Crohn's disease. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
| FG001 | Rheumatoid Arthritis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2015 |
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| Baseline, Month 2 |
| Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Baseline, Month 4 |
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Baseline, Month 6 |
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Baseline, Month 6 |
| Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Baseline, Month 6 |
| Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Baseline, Month 6 |
| Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Baseline, Month 6 |
| Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Baseline, Month 6 |
| Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Baseline, Month 6 |
| Change From Baseline in K10 at Month 6 Across All Indications | The K10 is intended to yield a global measure of distress based on a questionnaire about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The K10 scale involves 10 questions about emotional states each with a 5-level response scale. Each item is scored from 1=none of the time to 5=all of the time. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. | Baseline, Month 6 |
| Change From Baseline in Flourishing Scale at Month 6 Across All Indications | The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Participants are asked to respond to 8 statements using a scale of 1 (strongly disagree) and 7 (strongly agree) for each item. The possible range of scores is from 8 (lowest possible) to 56 (highest possible), with higher scores representing more psychological resources and strengths. | Baseline, Month 6 |
| Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications | The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. The total score ranges from 8 to 56 with a higher score indicating a better condition. | Baseline, Month 6 |
| Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis | HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). | Baseline, Month 6 |
| Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease | The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. QoL is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL). | Baseline, Month 6 |
| Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis | The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect. | Baseline, Month 6 |
| Number of Participants Remaining on Treatment at Month 6 | The number of participants at 6 months who remained on adalimumab, having satisfied the requirements for application for renewal of subsidy by special authority. | Month 6 |
Participants with rheumatoid arthritis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
| FG002 | Psoriasis | Participants with psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
| Baseline WHODAS Data Recorded |
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Participants with baseline WHODAS data recorded. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, corresponding baseline data are presented for all participants as a single group.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Indications | Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Response Score | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Participants with baseline and Month 6 assessments in each of the indication categories. | Mean | Standard Deviation | units on a scale |
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| Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) V2.0: Absenteeism | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with a baseline and Month 6 assessment. | Mean | Standard Deviation | percentage of work time missed |
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| WPAI-GH v2.0: Presenteeism | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with a baseline and Month 6 assessment. | Mean | Standard Deviation | percentage impairment time |
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| WPAI-GH v2.0: Work Productivity Loss | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with a baseline and Month 6 assessment. | Mean | Standard Deviation | percentage overall work impairment |
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| WPAI-GH v2.0: Activity Impairment | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with a baseline and Month 6 assessment. | Mean | Standard Deviation | percentage of activity impairment |
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| Kessler Psychological Distress Scale (K10) | The K10 questionnaire is intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4-week period. In this 10-item questionnaire, scores are summed and range from 10 to 50. Patients with a score under 20 are likely to be well, those with a score 20-24 are likely to have a mild mental disorder, those with a score 25-29 are likely to have a moderate mental disorder and those with a score 30 and over are likely to have a severe mental disorder. | Participants with a baseline and Month 6 assessment. | Mean | Standard Deviation | units on a scale |
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| Flourishing Scale | The Flourishing Scale consists of eight items describing important aspects of human functioning ranging from positive relationships, to feelings of competence, to having meaning and purpose in life. Patients respond to the eight questions using responses varying between 1 (strongly disagree) and 7 (strongly agree). For the scoring, the responses are added such that the range of scores is 8 (lowest possible) to 56 (highest possible). While there is no set cut point to define disability, a high score represents a person with many psychological resources and strengths. | Participants with a baseline and Month 6 assessment. | Mean | Standard Deviation | units on a scale |
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| Subjective Vitality Scale | The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. | Participants with a baseline and Month 6 assessment. | Mean | Standard Deviation | units on a scale |
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| Health Assessment Questionnaire Disability Index (HAQ-DI) | HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). | Participants with rheumatoid arthritis and a baseline and Month 6 assessment. | Mean | Standard Deviation | units on a scale |
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| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. Quality of life (QoL) is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL). | Participants with Crohn's disease and baseline and Month 6 assessments. | Mean | Standard Deviation | units on a scale |
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| Dermatology Life Quality Index (DLQI) Score | The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect. | Participants with psoriasis and a baseline and Month 6 assessment. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Participants with baseline and Month 2 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 2 |
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| Secondary | Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Participants with baseline and Month 4 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4 |
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| Secondary | Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Participants with Crohn's disease and baseline and Month 6 assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Participants with psoriasis and baseline and Month 6 assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis | WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability. | Participants with rheumatoid arthritis and baseline and Month 6 assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | percentage of work time missed | Baseline, Month 6 |
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| Secondary | Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | percentage impairment time | Baseline, Month 6 |
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| Secondary | Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | percentage overall work impairment | Baseline, Month 6 |
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| Secondary | Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment | WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | percentage of activity impariment | Baseline, Month 6 |
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| Secondary | Change From Baseline in K10 at Month 6 Across All Indications | The K10 is intended to yield a global measure of distress based on a questionnaire about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The K10 scale involves 10 questions about emotional states each with a 5-level response scale. Each item is scored from 1=none of the time to 5=all of the time. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Flourishing Scale at Month 6 Across All Indications | The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Participants are asked to respond to 8 statements using a scale of 1 (strongly disagree) and 7 (strongly agree) for each item. The possible range of scores is from 8 (lowest possible) to 56 (highest possible), with higher scores representing more psychological resources and strengths. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications | The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. The total score ranges from 8 to 56 with a higher score indicating a better condition. | Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis | HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). | Participants with rheumatoid arthritis baseline and Month 6 assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease | The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. QoL is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL). | Participants with Crohn's disease and baseline and Month 6 assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis | The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect. | Participants with psoriasis and baseline and Month 6 assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Number of Participants Remaining on Treatment at Month 6 | The number of participants at 6 months who remained on adalimumab, having satisfied the requirements for application for renewal of subsidy by special authority. | Participants completing the study at 6 months. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group. | Posted | Count of Participants | Participants | Month 6 |
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From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Indications | Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. | 1 | 164 | 18 | 164 | 65 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Gastritis erosive | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Ileal stenosis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal hernia | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 21.0 | Systematic Assessment | death due to unknown cause |
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| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Stoma complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Drug intolerance | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Ulcer | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
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| Adenovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Candida infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Kidney infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Glycosylated haemoglobin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Liver function test increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
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| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Sensory disturbance | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
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| Peyronie's disease | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Nov 19, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D001172 | Arthritis, Rheumatoid |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
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