An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 168
- Primary Endpoint
- Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
Study Overview
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 (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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
Time Frame: 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.
Secondary Outcomes
- Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism(Baseline, Month 6)
- Change From Baseline in K10 at Month 6 Across All Indications(Baseline, Month 6)
- Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications(Baseline, Month 4)
- Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications(Baseline, Month 2)
- Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease(Baseline, Month 6)
- Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment(Baseline, Month 6)
- Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis(Baseline, Month 6)
- Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism(Baseline, Month 6)
- Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss(Baseline, Month 6)
- Change From Baseline in Flourishing Scale at Month 6 Across All Indications(Baseline, Month 6)
- Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease(Baseline, Month 6)
- Number of Participants Remaining on Treatment at Month 6(Month 6)
- Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis(Baseline, Month 6)
- Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis(Baseline, Month 6)
- Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications(Baseline, Month 6)
- Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis(Baseline, Month 6)