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

AbbVie

Status: Completed

Conditions: Psoriasis; Crohn's Disease; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02451839

P15-345

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

168 participants in 3 patient groups

Crohn's Disease

Description:

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

Description:

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

Description:

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.