An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-06

Study Completion Date

2017-12-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease Rheumatoid Arthritis Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No