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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-07-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with moderate to severe rheumatic disease

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

No interventions assigned to this group

Eligibility Criteria

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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.