Clinical trial NCT03608657: Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)
Official title: Observational Study Evaluating the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Keywords: Psoriatic Arthritis
Canada
CC-10004
Apremilast
APPRAISE
Safety
Non-interventional
Observation
DMARDs
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 102
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: Adult patients with active PsA and access to commercial Otezla® who are under the care of a Canadian rheumatologist.

Brief summary: This will be a Canadian observational study utilizing a prospective cohort design. Patients with active psoriatic arthritis (PsA) for whom the treating physician has decided, prior to and independently of enrollment in the study, to initiate treatment with Otezla® will be considered for participation in the study.

Patients will be enrolled from the practices of predominantly community rheumatologists and will be followed for 12 months from the time of initiation of treatment with Otezla® In line with the observational nature of the study, there will be no protocol imposed tests or assessments. However, recommended follow up visits will be at 4, 8 and 12 months. In addition, patients may be asked to voluntarily complete self-administered questionnaires.

The 24-month assessment will be aimed to determine whether or not treatment with Otezla® has been maintained, and if not, to ascertain the reason for discontinuation and what new treatment was initiated following discontinuation of Otezla®


Eligibility criteria: Inclusion Criteria:

* Active psoriatic arthritis (PsA) as per the Classification criteria for Psoriatic Arthritis (CASPAR) criteria, based on the investigator's clinical judgement.
* Adult patients (≥18 years of age) with PsA
* Prescribing physician has decided to initiate treatment with Otezla®, and this decision was prior to and independent of patient enrollment in the study.
* Access to commercially available Otezla®

Exclusion Criteria:

* Patients who are pregnant, breastfeeding, or who are planning on becoming pregnant during the course of the study
* Participation in Investigational Clinical Trial within the last 60 days.

Primary outcomes:
measure: The rate of achieving Low Disease Activity (LDA)
timeFrame: Up to approximately 1 year
Secondary outcomes:
measure: The rate of achieving Low Disease Activity (LDA)
timeFrame: Up to approximately 8 months
measure: Tender Joint Count (TJC)
timeFrame: Up to Approximately 1 year
measure: Swollen Joint Count (SJC)
timeFrame: Up to Approximately 1 year
measure: Assessment of Enthesitis (Leeds Enthesitis Index (LEI)
timeFrame: Up to Approximately 1 year
measure: Assessment of Dactylitis (Leeds Dactylitis Index)
timeFrame: Up to approximately 1 year
measure: Assessment of Body Surface Area (BSA)
timeFrame: Up to approximately 1 year
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Up to approximately 1 year
measure: Physician global assessment of disease activity (MDGA)
timeFrame: Up to approximately 1 year
measure: Patient global assessment of disease activity (PtGA)
timeFrame: Up to approximately 1 year
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Up to approximately 1 year
measure: Patient subjective assessment of Pain using a 100mm VAS
timeFrame: Up to approximately 1 year
measure: Psoriatic Arthritis (WPAI:PsA)
timeFrame: Up to approximately 1 year
measure: Medical Outcomes Study Short- Form 36 (SF-36)
timeFrame: Up to approximately 1 year
measure: Patient-reported adherence with PsA treatment from the last visit.
timeFrame: Up to approximately 1 year
measure: Proportion of patients in Patient Acceptable Symptom State (PASS)
timeFrame: Up to approximately 1 year
measure: Adverse Events (AEs)
timeFrame: From enrollment until at least 28 days after completion of study treatment
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: The Waterside Clinic
city: Burlington
country: Canada
facility: The Arthritis and Osteoporosis Centre
city: Hamilton
country: Canada
facility: Adachi Medicine Professional Corporation
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology
city: Montreal
country: Canada
facility: Institut de Recherche en Rhumatologie de Montréal
city: Montreal
country: Canada
facility: Applied Medical Informatics Research Inc. (A.M.I.R.)
city: New Westminster
country: Canada
facility: Brent Appleton Clinic New Westminster
city: Oakville
country: Canada
facility: Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic
city: Penticton
country: Canada
facility: Drs M&W Teo
city: Quebec
country: Canada
facility: Groupe de recherche en maladies osseuses Inc.
city: Rimouski
country: Canada
facility: Centre de Rhumatologie de l'Est du Quebec
city: Saskatoon
country: Canada
facility: Polmed Research Inc.
city: Sherbrooke
country: Canada
facility: Clinique Jacques Cartier
city: St John's
country: Canada
facility: St. Clare's Mercy Hospital
city: Sydney
country: Canada
facility: Dr. Juris Lazovskis Incorporated
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
city: Toronto
country: Canada
facility: Arthur Karasik Medicine Professional Inc.
city: Vancouver
country: Canada
facility: Dr. Jonathan D. Chan Inc.
city: Windsor
country: Canada
facility: Dr. Sabeen Anwar Medicine Professional Corporation
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: