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)

June 4, 2024 updated by: Amgen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of achieving Low Disease Activity (LDA)
Time Frame: Up to approximately 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The rate of achieving Low Disease Activity (LDA)
Time Frame: Up to approximately 8 months
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)
Time Frame: Up to Approximately 1 year
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)
Time Frame: Up to Approximately 1 year
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)
Time Frame: Up to Approximately 1 year
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)
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
height (cm) x weight (kg)/3600)½
Up to approximately 1 year
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
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
Time Frame: Up to approximately 1 year
Patient subjective assessment of Pain using a 100mm VAS
Up to approximately 1 year
Psoriatic Arthritis (WPAI:PsA)
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
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.
Time Frame: Up to approximately 1 year
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)
Time Frame: Up to approximately 1 year
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)
Time Frame: From enrollment until at least 28 days after completion of study treatment
Number of subjects with adverse events
From enrollment until at least 28 days after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-10004-PSA-011
  • U1111-1214-0693 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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