An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY) (VITALITY)
19 de março de 2019 atualizado por: AbbVie
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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
168
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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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.
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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.
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
Prazo: Baseline, Month 6
|
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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Baseline, Month 6
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications
Prazo: Baseline, Month 2
|
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
|
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Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications
Prazo: Baseline, Month 4
|
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
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Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease
Prazo: Baseline, Month 6
|
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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Baseline, Month 6
|
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Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis
Prazo: Baseline, Month 6
|
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
Prazo: Baseline, Month 6
|
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
|
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Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism
Prazo: Baseline, Month 6
|
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.
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Baseline, Month 6
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Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism
Prazo: Baseline, Month 6
|
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
Prazo: Baseline, Month 6
|
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
Prazo: Baseline, Month 6
|
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
|
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Change From Baseline in K10 at Month 6 Across All Indications
Prazo: Baseline, Month 6
|
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.
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Baseline, Month 6
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Change From Baseline in Flourishing Scale at Month 6 Across All Indications
Prazo: Baseline, Month 6
|
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.
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Baseline, Month 6
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Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications
Prazo: Baseline, Month 6
|
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.
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Baseline, Month 6
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Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis
Prazo: Baseline, Month 6
|
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).
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Baseline, Month 6
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Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease
Prazo: Baseline, Month 6
|
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).
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Baseline, Month 6
|
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Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis
Prazo: Baseline, Month 6
|
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.
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Baseline, Month 6
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Number of Participants Remaining on Treatment at Month 6
Prazo: 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.
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Month 6
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
6 de julho de 2015
Conclusão Primária (Real)
5 de dezembro de 2017
Conclusão do estudo (Real)
5 de dezembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
20 de maio de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de maio de 2015
Primeira postagem (Estimativa)
22 de maio de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de junho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de março de 2019
Última verificação
1 de janeiro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P15-345
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Indeciso
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .