Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)
APPRAISE
Observational Study Evaluating the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)
2 other identifiers
observational
102
1 country
19
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®
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2018
CompletedStudy Start
First participant enrolled
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedJune 5, 2024
June 1, 2024
2.7 years
May 30, 2018
June 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
The rate of achieving Low Disease Activity (LDA)
Up to approximately 8 months
Tender Joint Count (TJC)
Up to Approximately 1 year
Swollen Joint Count (SJC)
Up to Approximately 1 year
Assessment of Enthesitis (Leeds Enthesitis Index (LEI)
Up to Approximately 1 year
Assessment of Dactylitis (Leeds Dactylitis Index)
Up to approximately 1 year
- +11 more secondary outcomes
Study Arms (1)
Psoriatic Arthritis patients treated with Apremilast
Active PsA as per the CASPAR criteria, based on the investigator's clinical judgement with access to commercially available Otezla
Interventions
Eligibility Criteria
Adult patients with active PsA and access to commercial Otezla® who are under the care of a Canadian rheumatologist.
You may qualify if:
- 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®
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (19)
The Waterside Clinic
Barrie, L4M 6L2, Canada
The Arthritis and Osteoporosis Centre
Burlington, L7L 0B7, Canada
Adachi Medicine Professional Corporation
Hamilton, L8N 1Y2, Canada
Credit Valley Rheumatology
Mississauga, L5M 2V8, Canada
Institut de Recherche en Rhumatologie de Montréal
Montreal, H2L 1S6, Canada
Applied Medical Informatics Research Inc. (A.M.I.R.)
Montreal, H4A 3T2, Canada
Brent Appleton Clinic New Westminster
New Westminster, V6Z 2C7, Canada
Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic
Oakville, L6M 4J2, Canada
Drs M&W Teo
Penticton, V2A 4Z1, Canada
Groupe de recherche en maladies osseuses Inc.
Québec, G1V 3M7, Canada
Centre de Rhumatologie de l'Est du Quebec
Rimouski, G5L 8W1, Canada
Polmed Research Inc.
Saskatoon, S7N 4A4, Canada
Clinique Jacques Cartier
Sherbrooke, J1J 2E3, Canada
St. Clare's Mercy Hospital
St. John's, A1A 5B8, Canada
Dr. Juris Lazovskis Incorporated
Sydney, B1S 3N1, Canada
Toronto Western Hospital, University Health Network
Toronto, M5T 2S8, Canada
Arthur Karasik Medicine Professional Inc.
Toronto, M9C 5N2, Canada
Dr. Jonathan D. Chan Inc.
Vancouver, V5Z 1J9, Canada
Dr. Sabeen Anwar Medicine Professional Corporation
Windsor, N8X 5A6, Canada
Related Publications (1)
Chandran V, Bessette L, Thorne C, Sheriff M, Rahman P, Gladman DD, Anwar S, Jelley J, Gaudreau AJ, Chohan M, Sampalis JS. Use of Apremilast to Achieve Psoriatic Arthritis Treatment Goals and Satisfaction at 1 Year in the Canadian Real-World APPRAISE Study. Rheumatol Ther. 2024 Apr;11(2):443-455. doi: 10.1007/s40744-024-00641-w. Epub 2024 Feb 28.
PMID: 38416391DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2018
First Posted
August 1, 2018
Study Start
July 31, 2018
Primary Completion
April 12, 2021
Study Completion
March 30, 2022
Last Updated
June 5, 2024
Record last verified: 2024-06