Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium (SPACTIVE)

Observational Study in AS and PsA Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium

This observational study will document to what extent in daily clinical practice the work productivity is affected before and after the start of adalimumab treatment.

Changes in the employment status and work productivity of participants with AS and PsA before and after the start of adalimumab will be noted. The relationship between employment status, work productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA might be diseases with a strong impact on the daily life of the participant, an evaluation will be performed to the effect of the disease on quality of life and work productivity.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis; Ankylosing Spondylitis

• Study Type: Observational
• Enrollment (Actual): 183

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with AS and PsA followed in university or peripheral hospitals or peripheral private practices with experience in AS and PsA care.

Description

Inclusion Criteria:

• Patient >= 18 years and <= 50 years
• Patient diagnosed with AS or PsA
• Patient to be initiated on adalimumab (according to the Marketing Authorization and Belgian reimbursement criteria)
• Patient willing to sign informed consent

Exclusion Criteria:

• Any contraindication for adalimumab as specified in the corresponding Summary of Product Characteristics (SmPC)
• Patient previously treated with biologics
• Patient participating in other AbbVie-sponsored trials

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ankylosing Spondylitis and Psoriatic Arthritis; Participants with AS and PsA and in whom adalimumab treatment is initiated. All medication will be prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)	The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)* [number of hours worked / (number of hours of work missed due to disease + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.	Baseline, Month 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)	The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)* [number of hours worked / (number of hours of work missed due to disease + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.	Baseline, Month 18
Number of Participants Employed at Each Assessed Visit	As assessed by the WPAI questionnaire, a questionnaire used to evaluate lost work productivity due to disease (yes=employed; no=not employed). Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit	Absenteeism, presented as the mean percentage of work time missed due to disease (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to disease / (number of hours of work missed due to disease + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit	Activity impairment due to disease (the extent to which disease affected the ability to perform usual daily activities, as reported on the WPAI) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit	As measured by the WPAI-Specific Health Problem questionnaire. Presenteeism (the extent to which disease decreased productivity, as reported on the WPAI) is presented as the mean percentage of impairment while working due to disease, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)	The HAQ-DI is a self-reported assessment of how the participant's disease affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores: dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. Scores range from 0 to 3, with a lower score demonstrating less disability. Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)	The DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0); responses are summed. The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)	The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)	The DAS-28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS-28 score. Scores on the DAS-28 range from 0 to 10. A DAS-28 score > 5.1 indicates high disease activity, a DAS-28 score < 3.2 indicates low disease activity, and a DAS-28 score < 2.6 indicates clinical remission. Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)	Percentage of BSA affected by psoriatic arthritis was assessed by clinical evaluation. Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)	The BASDAI is used for measuring and evaluating disease activity in ankylosing spondylitis. This index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0 to 10 (0 being no problem and 10 being the worst problem). Last observation is the last observation after baseline at which any of the questionnaire items was completed.	Baseline, Months 3, 6, 12, 18
Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time	The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. Last observation is the last observation after baseline at which an assessment was completed.	Baseline, Months 3, 6, 12, 18
Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time	CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. Last observation is the last observation after baseline at which an assessment was completed.	Baseline, Months 3, 6, 12, 18
Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time	The VAS score assessed by physicians was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).	Baseline, Months 3, 6, 12, 18
Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time	The VAS score assessed by participants was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).	Baseline, Months 3, 6, 12, 18
Participant's Global Assessment of Pain VAS Scores Over Time	The VAS score assessed by participants was used to determine the pain due to ankylosing spondylitis and 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).	Baseline, Months 3, 6, 12, 18

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2013
• Primary Completion (Actual): June 23, 2017
• Study Completion (Actual): June 23, 2017

Study Registration Dates

• First Submitted: May 1, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: multicenter study; work productivity
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Bone Diseases, Infectious; Ankylosis; Arthritis; Arthritis, Psoriatic; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: P13-990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No