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

NCT01282372 | Completed Results

• 1 other identifier: P12-179
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

Ankylosing spondylitis; Sleep; Psoriatic arthritis; Work Productivity; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Mean Change From Baseline in Work Time Missed Due to Health Problem

  The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

  Baseline (Day 1) and Month 24

• Mean Change From Baseline in Impairment While Working Due to Health Problem

  The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

  Baseline (Day 1) and Month 24

• Mean Change From Baseline in Overall Work Impairment Due to Health Problem

  The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

  Baseline (Day 1) and Month 24

• Mean Change From Baseline in Overall Activity Impairment Due to Health Problem

  The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

  Baseline (Day 1) and Month 24

Secondary Outcomes (13)

• Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups

  Baseline (Day 1) and Month 24

• Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups

  Baseline (Day 1) and Month 24

• Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups

  Baseline (Day 1) and Month 24

• Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups

  Baseline (Day 1) and Month 24

• Mean Disease Activity Score 28 (DAS28)

  Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Theofilos Karatsourakis, MD

  AbbVie Pharmaceuticals S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 25, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 9, 2015
• Results First Posted: August 26, 2015

Record last verified: 2015-10