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

NCT ID: NCT03608657

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2022-03-30

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®

Detailed Description

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Conditions

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Arthritis, Psoriatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Apremilast

Intervention Type DRUG

Apremilast

Interventions

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Apremilast

Apremilast

Intervention Type DRUG

Other Intervention Names

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Otezla

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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The Waterside Clinic

Barrie, , Canada

Site Status

The Arthritis and Osteoporosis Centre

Burlington, , Canada

Site Status

Adachi Medicine Professional Corporation

Hamilton, , Canada

Site Status

Credit Valley Rheumatology

Mississauga, , Canada

Site Status

Institut de Recherche en Rhumatologie de Montréal

Montreal, , Canada

Site Status

Applied Medical Informatics Research Inc. (A.M.I.R.)

Montreal, , Canada

Site Status

Brent Appleton Clinic New Westminster

New Westminster, , Canada

Site Status

Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic

Oakville, , Canada

Site Status

Drs M&W Teo

Penticton, , Canada

Site Status

Groupe de recherche en maladies osseuses Inc.

Québec, , Canada

Site Status

Centre de Rhumatologie de l'Est du Quebec

Rimouski, , Canada

Site Status

Polmed Research Inc.

Saskatoon, , Canada

Site Status

Clinique Jacques Cartier

Sherbrooke, , Canada

Site Status

St. Clare's Mercy Hospital

St. John's, , Canada

Site Status

Dr. Juris Lazovskis Incorporated

Sydney, , Canada

Site Status

Toronto Western Hospital, University Health Network

Toronto, , Canada

Site Status

Arthur Karasik Medicine Professional Inc.

Toronto, , Canada

Site Status

Dr. Jonathan D. Chan Inc.

Vancouver, , Canada

Site Status

Dr. Sabeen Anwar Medicine Professional Corporation

Windsor, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 38416391 (View on PubMed)

Related Links

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Other Identifiers

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U1111-1214-0693

Identifier Type: OTHER

Identifier Source: secondary_id

CC-10004-PSA-011

Identifier Type: -

Identifier Source: org_study_id

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