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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02451839




Registration number
NCT02451839
Ethics application status
Date submitted
20/05/2015
Date registered
22/05/2015

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
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
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.

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.

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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
Timepoint [1] 0 0
Baseline, Month 6
Secondary outcome [1] 0 0
Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications
Timepoint [1] 0 0
Baseline, Month 2
Secondary outcome [2] 0 0
Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications
Timepoint [2] 0 0
Baseline, Month 4
Secondary outcome [3] 0 0
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease
Timepoint [3] 0 0
Baseline, Month 6
Secondary outcome [4] 0 0
Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis
Timepoint [4] 0 0
Baseline, Month 6
Secondary outcome [5] 0 0
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis
Timepoint [5] 0 0
Baseline, Month 6
Secondary outcome [6] 0 0
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism
Timepoint [6] 0 0
Baseline, Month 6
Secondary outcome [7] 0 0
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism
Timepoint [7] 0 0
Baseline, Month 6
Secondary outcome [8] 0 0
Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss
Timepoint [8] 0 0
Baseline, Month 6
Secondary outcome [9] 0 0
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment
Timepoint [9] 0 0
Baseline, Month 6
Secondary outcome [10] 0 0
Change From Baseline in K10 at Month 6 Across All Indications
Timepoint [10] 0 0
Baseline, Month 6
Secondary outcome [11] 0 0
Change From Baseline in Flourishing Scale at Month 6 Across All Indications
Timepoint [11] 0 0
Baseline, Month 6
Secondary outcome [12] 0 0
Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications
Timepoint [12] 0 0
Baseline, Month 6
Secondary outcome [13] 0 0
Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis
Timepoint [13] 0 0
Baseline, Month 6
Secondary outcome [14] 0 0
Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease
Timepoint [14] 0 0
Baseline, Month 6
Secondary outcome [15] 0 0
Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis
Timepoint [15] 0 0
Baseline, Month 6
Secondary outcome [16] 0 0
Number of Participants Remaining on Treatment at Month 6
Timepoint [16] 0 0
Month 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 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
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)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02451839