An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)

Study Overview
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Brief Summary
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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.

Official Title
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An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)

Conditions
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Crohn's Disease, Rheumatoid Arthritis, Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of rheumatoid arthritis, Crohn's disease or psoriasis who have made a decision with their physician to commence treatment with adalimumab in accordance with routine medical practice and with the approved adalimumab New Zealand Datasheet. Patients who have been evaluated for tuberculosis risk factors/exposure for active/latent tuberculosis infection (per local requirements and according to the approved adalimumab New Zealand Datasheet). Adult subjects, 18-75 years old, who have voluntarily signed and dated an informed consent form prior to any study-specific procedures. Exclusion Criteria: Previous treatment with adalimumab. Previous treatment with any biologic. Severe infection including sepsis, active tuberculosis or opportunistic infection. Moderate to severe heart failure (New York Heart Association Class II/III). Concurrent administration with anakinra. Hypersensitivity to adalimumab or its excipients. Any condition that in the opinion of the investigator would compromise the subject's well-being or ability to perform the study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's Disease<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease, Arthritis, Rheumatoid, Psoriasis, Patient Outcome Assessment, Adalimumab, Global Health, Quality of Life