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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01282372
First received: January 21, 2011
Last updated: July 28, 2015
Last verified: July 2015
  Purpose

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).


Condition
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Mean Change From Baseline in Work Time Missed Due to Health Problem [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Impairment While Working Due to Health Problem [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Overall Work Impairment Due to Health Problem [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Overall Activity Impairment Due to Health Problem [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    The 'work time missed 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 '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.

  • Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups [ Time Frame: Baseline (Day 1) and Month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Disease Activity Score 28 (DAS28) [ Time Frame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.

  • Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.

  • Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score [ Time Frame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.

  • Mean Psoriatic Arthritis Response Criteria (PsArC) Score [ Time Frame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The PsARC response could not be calculated, hence Psoriatic Arthritis disease activity was evaluated by the percentage of participants with tender and swollen joints, acute phase reactants (erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP)) and the participant and physician VAS scales.

  • Mean Visual Analogue Scale (VAS) Score [ Time Frame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.

  • Mean Sleep Disturbance Subscale Score [ Time Frame: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.


Enrollment: 500
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282372

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Theofilos Karatsourakis, MD AbbVie Pharmaceuticals S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01282372     History of Changes
Other Study ID Numbers: P12-179
Study First Received: January 21, 2011
Results First Received: July 28, 2015
Last Updated: July 28, 2015
Health Authority: Greece: National Organization of Medicines

Keywords provided by AbbVie:
Ankylosing spondylitis
Sleep
Psoriatic arthritis
Work Productivity
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Rheumatic Diseases
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2015