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 Overview
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Brief Summary
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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®

Official Title
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Observational Study Evaluating the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)

Conditions
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Arthritis, Psoriatic

Intervention / Treatment
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* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriatic Arthritis patients treated with Apremilast<br>Active PsA as per the CASPAR criteria, based on the investigator's clinical judgement with access to commercially available Otezla | Drug: Apremilast<br>* Apremilast<br>* Other names: Otezla;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of achieving Low Disease Activity (LDA) | Is defined as Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) < 14. cDAPSA is calculated as the sum of TJC - 68, SJC - 66, PtGA (10-cm VAS) and Pain (10-cm VAS). | Up to approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of achieving Low Disease Activity (LDA) | Is defined as Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) < 14. cDAPSA is calculated as the sum of TJC - 68, SJC - 66, PtGA (10-cm VAS) and Pain (10-cm VAS). | Up to approximately 8 months | 
| Tender Joint Count (TJC) | Based on 68/66 joints to determine joint pain/tenderness and joint swelling, as conducted during the physical examination and per the practices of the treating physician | Up to Approximately 1 year | 
| Swollen Joint Count (SJC) | Based on 68/66 joints to determine joint pain/tenderness and joint swelling, as conducted during the physical examination and per the practices of the treating physician | Up to Approximately 1 year | 
| Assessment of Enthesitis (Leeds Enthesitis Index (LEI) | This is completed by the treating physician and assesses tenderness at six (6) sites, specifically two (2) lateral at the following: epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. The LEI is scored between 0 and 6. Resolution versus improvement versus no change versus worsening of enthesitis since the last available assessment | Up to Approximately 1 year | 
| Assessment of Dactylitis (Leeds Dactylitis Index) | Resolution versus improvement versus no change versus worsening of dactylitis since the last available assessment | Up to approximately 1 year | 
| Assessment of Body Surface Area (BSA) | height (cm) x weight (kg)/3600)½ | Up to approximately 1 year | 
| Health Assessment Questionnaire Disability Index (HAQ-DI) | This is a self-administered questionnaire measuring the patient's functional ability during the last week. It consists of 20 items converging to 8 scales measuring dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The patients rate each activity as 0 = without any difficulty, 1 = some difficulty, 2 = much difficulty and 4 = unable. The final score ranges from 0 to 3 with higher scores indicating more disability. | Up to approximately 1 year | 
| Physician global assessment of disease activity (MDGA) | This is a 100-mm visual analog scale (VAS) with 0 indicating lowest disease and 100 highest disease activities | Up to approximately 1 year | 
| Patient global assessment of disease activity (PtGA) | This is a 100-mm VAS with 0 indicating lowest disease and 100 highest disease activity | Up to approximately 1 year | 
| Treatment Satisfaction Questionnaire for Medication (TSQM) | This is a 14-item questionnaire evaluating patient satisfaction in terms of the following: effectiveness, side effects, convenience, and global satisfaction | Up to approximately 1 year | 
| Patient subjective assessment of Pain using a 100mm VAS | Patient subjective assessment of Pain using a 100mm VAS | Up to approximately 1 year | 
| Psoriatic Arthritis (WPAI:PsA) | A 6-item questionnaire assessing the effect of PsA on the patient's ability to work and perform daily activities. It assesses presenteeism, absenteeism, productivity and activity impairment | Up to approximately 1 year | 
| Medical Outcomes Study Short- Form 36 (SF-36) | A generic quality of life index that is comprised of 36 items converging to eight (8) domains: Vitality, Physical Functioning, Bodily Pain, General Health Perception, Physical Role Functioning, Emotional Role Functioning, Social Role Functioning, and Mental Health | Up to approximately 1 year | 
| Patient-reported adherence with PsA treatment from the last visit. | An optional weekly take-home diary will be offered to patients; this diary will aid in documenting how many doses (if any) of PsA treatment were missed, and the reason(s) why. | Up to approximately 1 year | 
| Proportion of patients in Patient Acceptable Symptom State (PASS) | A single question phrased as If you were to remain for the next few months as you were during the last week, would this be acceptable or unacceptable to you? with a binary (Yes or No) response | Up to approximately 1 year | 
| Adverse Events (AEs) | Number of subjects with adverse events | From enrollment until at least 28 days after completion of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, Canada, CC-10004, Apremilast, APPRAISE, Safety, Non-interventional, Observation, DMARDs