Clinical trial NCT02451839: An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Rheumatoid Arthritis
Psoriasis
Keywords: Crohn Disease
Arthritis, Rheumatoid
Psoriasis
Patient Outcome Assessment
Adalimumab
Global Health
Quality of Life
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-05-22
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be males and/or females who are attending a routine clinical visit and meet all of the inclusion criteria and none of the exclusion criteria.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications
timeFrame: Baseline, Month 2
measure: Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications
timeFrame: Baseline, Month 4
measure: Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease
timeFrame: Baseline, Month 6
measure: Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis
timeFrame: Baseline, Month 6
measure: Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis
timeFrame: Baseline, Month 6
measure: Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism
timeFrame: Baseline, Month 6
measure: Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism
timeFrame: Baseline, Month 6
measure: Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss
timeFrame: Baseline, Month 6
measure: Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment
timeFrame: Baseline, Month 6
measure: Change From Baseline in K10 at Month 6 Across All Indications
timeFrame: Baseline, Month 6
measure: Change From Baseline in Flourishing Scale at Month 6 Across All Indications
timeFrame: Baseline, Month 6
measure: Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications
timeFrame: Baseline, Month 6
measure: Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis
timeFrame: Baseline, Month 6
measure: Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease
timeFrame: Baseline, Month 6
measure: Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis
timeFrame: Baseline, Month 6
measure: Number of Participants Remaining on Treatment at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Gearry RB, Frampton C, Inns S, Poppelwell D, Rademaker M, Suppiah R. VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand. Curr Med Res Opin. 2019 Oct;35(10):1837-1846. doi: 10.1080/03007995.2019.1634952. Epub 2019 Jul 3.