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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282372
• Other study ID #: P12-179
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: October 8, 2015
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups	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.	Baseline (Day 1) and Month 24	No
Secondary	Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups	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	No
Secondary	Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups	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	No
Secondary	Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups	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	No
Secondary	Mean Disease Activity Score 28 (DAS28)	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.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	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.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score	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.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Mean Psoriatic Arthritis Response Criteria (PsARC) Score	As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero	Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Mean Erythrocyte Sedimentation Rate (ESR)	Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Mean Plasma Concentrations of C-Reactive Protein (CRP)	Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Mean Visual Analogue Scale (VAS) Score	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.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No
Secondary	Mean Sleep Disturbance Subscale Score	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.	Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24	No

External Links

•   Link