An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY) (VITALITY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02451839|
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : January 23, 2018
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 (PRO) 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.
|Condition or disease|
|Crohn's Disease Rheumatoid Arthritis Psoriasis|
|Study Type :||Observational|
|Actual Enrollment :||168 participants|
|Official Title:||An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)|
|Actual Study Start Date :||July 6, 2015|
|Actual Primary Completion Date :||December 5, 2017|
|Actual Study Completion Date :||December 5, 2017|
Patients with Crohn's disease
Patients with rheumatoid arthritis
Patients with psoriasis
- Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 response score [ Time Frame: From month 0 to 6 ]The WHODAS 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.
- Change in Kessler Psychological Distress Scale (K10) [ Time Frame: From month 0 to 6 ]The K10 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.
- Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score in patients with Crohn's disease [ Time Frame: From month 0 to 6 ]The SIBDQ is a simple, validated, 10 item questionnaire, taken from the original 32 question IBDQ, that can be easily scored and interpreted by clinicians.
- Change in Subject Vitality Scale [ Time Frame: From month 0 to 6 ]The Subject Vitality Scale evaluates the state of feeling alive and alert -- to having energy available to the self.
- Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) score in patients with rheumatoid arthritis [ Time Frame: From month 0 to 6 ]The HAQ-DI was developed as a comprehensive measure of functional status in patients with a wide variety of rheumatic diseases.
- Change in Dermatology Life Quality Index (DLQI) score [ Time Frame: From month 0 to 6 ]The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
- Change in total WHODAS 2.0 score in adalimumab responder and non-responders population [ Time Frame: From month 0 to 6 ]Total WHODAS 2.0 score is assessed at 6 months after the initiation of adalimumab, in those patients continuing on adalimumab (responder population), compared with those patients not continuing on adalimumab (non-responders).
- Change in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) V2.0 score [ Time Frame: From month 0 to 6 ]This questionnaire looks at the effect of health problems on ability to work and perform regular activities
- Change in Flourishing Scale [ Time Frame: From month 0 to 6 ]The Flourishing Scale consists of 8 items describing important aspects of human functioning ranging from positive relationships, to feelings of competence, to having meaning and purpose in life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451839
|Hamilton, Waikato, New Zealand, 3204|
|North Shore Hospital|
|Auckland, New Zealand, 0622|
|Auckland City Hospital|
|Auckland, New Zealand, 1023|
|Middlemore Clinical Trials|
|Auckland, New Zealand, 2025|
|Canterbury District Health Boa|
|Christchurch, New Zealand, 8011|
|Memorial Avenue Consultancy|
|Christchurch, New Zealand, 8053|
|Dunedin, New Zealand, 9016|
|Hawke's Bay Hospital|
|Hawke's BAY, New Zealand|
|Lower Hutt, New Zealand, 5010|
|Porter Rheumatology Ltd|
|Nelson, New Zealand, 7010|
|Waitemata Distric Health Board|
|North Shore, New Zealand|
|Tauranga, BAY OF Plenty, New Zealand, 3143|
|Timaru, New Zealand|
|Wellington, New Zealand, 6021|
|Study Director:||AbbVie Inc.||AbbVie|