Clinical trial NCT01282372: Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab
Official title: A 2-year HRQL Observational Study Evaluating the Effect of Treatment With Adalimumab on Work Productivity and Sleep in Patients With Rheumatic Diseases in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: Ankylosing spondylitis
Sleep
Psoriatic arthritis
Work Productivity
Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label, as prescribed by the physicians under normal clinical practice.

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline in Work Time Missed Due to Health Problem
timeFrame: Baseline (Day 1) and Month 24
measure: Mean Change From Baseline in Impairment While Working Due to Health Problem
timeFrame: Baseline (Day 1) and Month 24
measure: Mean Change From Baseline in Overall Work Impairment Due to Health Problem
timeFrame: Baseline (Day 1) and Month 24
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem
timeFrame: Baseline (Day 1) and Month 24
Secondary outcomes:
measure: Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups
timeFrame: Baseline (Day 1) and Month 24
measure: Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups
timeFrame: Baseline (Day 1) and Month 24
measure: Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups
timeFrame: Baseline (Day 1) and Month 24
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups
timeFrame: Baseline (Day 1) and Month 24
measure: Mean Disease Activity Score 28 (DAS28)
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Mean Psoriatic Arthritis Response Criteria (PsARC) Score
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Mean Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Mean Plasma Concentrations of C-Reactive Protein (CRP)
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Mean Visual Analogue Scale (VAS) Score
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Mean Sleep Disturbance Subscale Score
timeFrame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Pharmaceuticals S.A.
name: Theofilos Karatsourakis, MD
role: STUDY_CHAIR
References: