Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab

AbbVie

Status: Completed

Conditions: Psoriatic Arthritis; Ankylosing Spondylitis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01282372

P12-179

Details and patient eligibility

About

Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an improvement in work productivity in participants with rheumatic diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and AS) and no data was available for the effect of adalimumab treatment on work productivity in PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted to evaluate the effect of treatment with adalimumab on work productivity and sleep disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and AS).

Full description

This was a multi-center, uncontrolled, prospective, observational study in participants with moderate to severe rheumatic disease (RA, PsA, or AS) who received adalimumab under normal clinical practice in accordance with Summary of Product Characteristics (SmPC), with or without other anti-rheumatic treatments.

Enrollment: 500 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with moderate or severe active rheumatic disease, who received adalimumab under normal clinical practice in accordance with the approved local SmPC.
2. Participants who provided their consent for data collection and use by AbbVie.

Exclusion criteria

1. Contraindications according to the SmPC.
2. Participants who did not participate in other observational studies conducted by Abbvie.

Trial design

500 participants in 1 patient group

Participants with moderate to severe rheumatic disease

Description:

Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label