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)

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®

Study Overview

• Status: Completed
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Apremilast

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Canada
  • Barrie, Canada, L4M 6L2
    • The Waterside Clinic
  • Burlington, Canada, L7L 0B7
    • The Arthritis and Osteoporosis Centre
  • Hamilton, Canada, L8N 1Y2
    • Adachi Medicine Professional Corporation
  • Mississauga, Canada, L5M 2V8
    • Credit Valley Rheumatology
  • Montreal, Canada, H2L 1S6
    • Institut de Recherche en Rhumatologie de Montréal
  • Montreal, Canada, H4A 3T2
    • Applied Medical Informatics Research Inc. (A.M.I.R.)
  • New Westminster, Canada, V6Z 2C7
    • Brent Appleton Clinic New Westminster
  • Oakville, Canada, L6M 4J2
    • Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic
  • Penticton, Canada, V2A 4Z1
    • Drs M&W Teo
  • Quebec, Canada, G1V 3M7
    • Groupe de recherche en maladies osseuses Inc.
  • Rimouski, Canada, G5L 8W1
    • Centre de Rhumatologie de l'Est du Quebec
  • Saskatoon, Canada, S7N 4A4
    • Polmed Research Inc.
  • Sherbrooke, Canada, J1J 2E3
    • Clinique Jacques Cartier
  • St John's, Canada, A1A 5B8
    • St. Clare's Mercy Hospital
  • Sydney, Canada, B1S 3N1
    • Dr. Juris Lazovskis Incorporated
  • Toronto, Canada, M5T 2S8
    • Toronto Western Hospital, University Health Network
  • Toronto, Canada, M9C 5N2
    • Arthur Karasik Medicine Professional Inc.
  • Vancouver, Canada, V5Z 1J9
    • Dr. Jonathan D. Chan Inc.
  • Windsor, Canada, N8X 5A6
    • Dr. Sabeen Anwar Medicine Professional Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Apremilast; Apremilast; Other Names: Otezla

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website
• Expanded Access for CC-10004

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Psoriatic Arthritis; CC-10004; Apremilast; DMARDs; Non-interventional; Observation; Canada; APPRAISE
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: CC-10004-PSA-011; U1111-1214-0693 (Other Identifier: UTN)