Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment with Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)
Study Details
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®
Protocol Summary
The rate of achieving Low Disease Activity (LDA)
Timeframe: Up to approximately 1 year
The rate of achieving Low Disease Activity (LDA)
Timeframe: Up to approximately 8 months
Tender Joint Count (TJC)
Timeframe: Up to Approximately 1 year
Swollen Joint Count (SJC)
Timeframe: Up to Approximately 1 year
Assessment of Enthesitis (Leeds Enthesitis Index (LEI)
Timeframe: Up to Approximately 1 year
Assessment of Dactylitis (Leeds Dactylitis Index)
Timeframe: Up to approximately 1 year
Assessment of Body Surface Area (BSA)
Timeframe: Up to approximately 1 year
Health Assessment Questionnaire Disability Index (HAQ-DI)
Timeframe: Up to approximately 1 year
Physician global assessment of disease activity (MDGA)
Timeframe: Up to approximately 1 year
Patient global assessment of disease activity (PtGA)
Timeframe: Up to approximately 1 year
Treatment Satisfaction Questionnaire for Medication (TSQM)
Timeframe: Up to approximately 1 year
Patient subjective assessment of Pain using a 100mm VAS
Timeframe: Up to approximately 1 year
Psoriatic Arthritis (WPAI:PsA)
Timeframe: Up to approximately 1 year
Medical Outcomes Study Short- Form 36 (SF-36)
Timeframe: Up to approximately 1 year
Patient-reported adherence with PsA treatment from the last visit.
Timeframe: Up to approximately 1 year
Proportion of patients in Patient Acceptable Symptom State (PASS)
Timeframe: Up to approximately 1 year
Adverse Events (AEs)
Timeframe: From enrollment until at least 28 days after completion of study treatment