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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/show/NCT02451839
Registration number
NCT02451839
Ethics application status
Date submitted
20/05/2015
Date registered
22/05/2015
Date last updated
23/01/2018
Titles & IDs
Public title
An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
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Scientific title
An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
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Secondary ID [1]
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P15-345
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Universal Trial Number (UTN)
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Trial acronym
VITALITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Rheumatoid Arthritis
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Psoriasis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Crohn's disease - Patients with Crohn's disease
Rheumatoid arthritis - Patients with rheumatoid arthritis
Psoriasis - Patients with psoriasis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 response score - 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.
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Timepoint [1]
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From month 0 to 6
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Secondary outcome [1]
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Change in Kessler Psychological Distress Scale (K10) - 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.
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Timepoint [1]
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From month 0 to 6
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Secondary outcome [2]
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Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score in patients with Crohn's disease - 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.
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Timepoint [2]
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From month 0 to 6
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Secondary outcome [3]
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Change in Subject Vitality Scale - The Subject Vitality Scale evaluates the state of feeling alive and alert -- to having energy available to the self.
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Timepoint [3]
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From month 0 to 6
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Secondary outcome [4]
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Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) score in patients with rheumatoid arthritis - The HAQ-DI was developed as a comprehensive measure of functional status in patients with a wide variety of rheumatic diseases.
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Timepoint [4]
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From month 0 to 6
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Secondary outcome [5]
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Change in Dermatology Life Quality Index (DLQI) score - The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
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Timepoint [5]
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From month 0 to 6
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Secondary outcome [6]
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Change in total WHODAS 2.0 score in adalimumab responder and non-responders population - 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).
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Timepoint [6]
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From month 0 to 6
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Secondary outcome [7]
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Change in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) V2.0 score - This questionnaire looks at the effect of health problems on ability to work and perform regular activities
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Timepoint [7]
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From month 0 to 6
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Secondary outcome [8]
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Change in Flourishing Scale - 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.
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Timepoint [8]
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From month 0 to 6
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Eligibility
Key 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
data sheet.
- 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).
- Subject has voluntarily signed and dated an informed consent form prior to any
study-specific procedures.
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Minimum age
18
Years
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Maximum age
75
Years
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/12/2017
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Sample size
Target
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Accrual to date
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Final
168
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Waikato
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Country [3]
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New Zealand
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State/province [3]
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Christchurch
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Country [4]
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New Zealand
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State/province [4]
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Dunedin
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Country [5]
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New Zealand
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State/province [5]
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Hawke's BAY
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Country [6]
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New Zealand
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State/province [6]
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Lower Hutt
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Country [7]
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New Zealand
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State/province [7]
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Nelson
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Country [8]
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New Zealand
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State/province [8]
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North Shore
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Country [9]
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New Zealand
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State/province [9]
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Tauranga, BAY OF Plenty
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Country [10]
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New Zealand
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State/province [10]
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Timaru
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Country [11]
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New Zealand
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State/province [11]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/show/NCT02451839
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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AbbVie Inc.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary results
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Other publications
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