Clinical trial NCT01845818: 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
Official title: Observational Study in AS and PsA Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: work productivity
multicenter study
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)
timeFrame: Baseline, Month 18
Secondary outcomes:
measure: Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)
timeFrame: Baseline, Month 18
measure: Number of Participants Employed at Each Assessed Visit
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time
timeFrame: Baseline, Months 3, 6, 12, 18
measure: Participant's Global Assessment of Pain VAS Scores Over Time
timeFrame: Baseline, Months 3, 6, 12, 18
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: