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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)
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)
Secondary ID [1] 0 0
P15-345
Universal Trial Number (UTN)
Trial acronym
VITALITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Rheumatoid Arthritis 0 0
Psoriasis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Crohn's disease - Patients with Crohn's disease

Rheumatoid arthritis - Patients with rheumatoid arthritis

Psoriasis - Patients with psoriasis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From month 0 to 6
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
From month 0 to 6
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
From month 0 to 6
Secondary outcome [3] 0 0
Change in Subject Vitality Scale - The Subject Vitality Scale evaluates the state of feeling alive and alert -- to having energy available to the self.
Timepoint [3] 0 0
From month 0 to 6
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
From month 0 to 6
Secondary outcome [5] 0 0
Change in Dermatology Life Quality Index (DLQI) score - The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
Timepoint [5] 0 0
From month 0 to 6
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
From month 0 to 6
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
From month 0 to 6
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
From month 0 to 6

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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/12/2017
Sample size
Target
Accrual to date
Final
168
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Waikato
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Dunedin
Country [5] 0 0
New Zealand
State/province [5] 0 0
Hawke's BAY
Country [6] 0 0
New Zealand
State/province [6] 0 0
Lower Hutt
Country [7] 0 0
New Zealand
State/province [7] 0 0
Nelson
Country [8] 0 0
New Zealand
State/province [8] 0 0
North Shore
Country [9] 0 0
New Zealand
State/province [9] 0 0
Tauranga, BAY OF Plenty
Country [10] 0 0
New Zealand
State/province [10] 0 0
Timaru
Country [11] 0 0
New Zealand
State/province [11] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02451839
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications