Study Complete
Sponsor ID
CC-10004-PSA-009
A study of apremilast use and effectiveness in patients with psoriatic arthritis in The NetherlandsREWARD
Study Details
This is a multicenter, prospective, non-interventional, observational single arm study.
100 patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.
Protocol Summary
Primary Outcome Measures
Percentage of patients with a Health Assessment Questionnaire – Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline
Timeframe: Up to 24 months
Secondary Outcome Measures
Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point
Timeframe: Up to 24 months
Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points
Timeframe: Up to 24 months
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6
Timeframe: Up to 6 months
Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6
Timeframe: Up to 6 months
Change from Baseline in Short Form 36 (SF36) at 12 months
Timeframe: Up to 12 months
Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months
Timeframe: Up to 12 months
Change from Baseline in visual analogue scales (VAS) at various time point
Timeframe: Up to 24 months
Locations
Location
Research Site
Breda, Netherlands, 4818 CK
Status
Recruiting
Location
Research Site
Gorinchem, Netherlands, 4204 AA
Status
Recruiting
Location
Research Site
Gouda, Netherlands, 2803 HH
Status
Recruiting
Location
Research Site
Harderwijk, Netherlands, 3844 DG
Status
Recruiting
Location
Research Site
Leeuwarden, Netherlands, 8934 AD
Status
Recruiting
Location
Research Site
Roosendaal, Netherlands, 4707 CH
Status
Recruiting
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