Clinical trial NCT02875184: A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
Official title: Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Keywords: Psoriatic Arthritis
Apremilast
CC-10004
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-08-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two hundred adult patients treated with apremilast for psoriatic arthritis will be recruited. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.

Brief summary: 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.

Detailed description: The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).

Eligibility criteria: Inclusion Criter

* Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
* Patients starting treatment with apremilast for psoriatic arthritis.

Exclusion Criteria:

* Refusal to participate in the study.
* Language barrier for completing the questionnaires.
* Women who are pregnant or breast-feeding.
* Hypersensitivity to the active substance or to any of the excipients.
* Prior exposure to apremilast
* Initiation of apremilast treatment by a dermatologist for psoriasis

Primary outcomes:
measure: 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 outcomes:
measure: Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point
timeFrame: Up to 24 months
measure: Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points
timeFrame: Up to 24 months
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6
timeFrame: Up to 6 months
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6
timeFrame: Up to 6 months
measure: Change from Baseline in Short Form 36 (SF36) at 12 months
timeFrame: Up to 12 months
measure: Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months
timeFrame: Up to 12 months
measure: Change from Baseline in visual analogue scales (VAS) at various time point
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Lelystad/Emmeloord
country: Netherlands
facility: Reumazorg ZWN
state: Flevoland
city: Leeuwarden
country: Netherlands
facility: MC Leeuwarden
state: Friesland
city: Harderwijk
country: Netherlands
facility: St. Jansdal
state: Gelderland
city: Venlo
country: Netherlands
facility: Viecuri Medisch Centrum
state: Limburg
city: Roosendaal
country: Netherlands
facility: Reumazorg ZWN
state: Noord-Brabant
city: Breda
country: Netherlands
facility: Amphia
state: North-Brabant
city: Helmond
country: Netherlands
facility: Elkerliek ziekenhuis
state: North-Brabant
city: Gorinchem
country: Netherlands
facility: Beatrix Ziekenhuis
state: South-Holland
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
state: South-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: South-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: South-Holland
city: Goes
country: Netherlands
facility: Reumazorg ZWN
state: Zeeland
city: Breda
country: Netherlands
facility: Research Site
city: Gorinchem
country: Netherlands
facility: Research Site
city: Gouda
country: Netherlands
facility: Research Site
city: Harderwijk
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Roosendaal
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Venlo
country: Netherlands
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: