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 Purpose

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®

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03608657
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Psoriatic
Study Website: View Trial Website
Arms & Interventions

Arms

: 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

Drug: - Apremilast

Apremilast

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Waterside Clinic, Barrie, Canada

Status

Recruiting

Address

The Waterside Clinic

Barrie, , L4M 6L2

The Arthritis and Osteoporosis Centre, Burlington, Canada

Status

Recruiting

Address

The Arthritis and Osteoporosis Centre

Burlington, , L7L 0B7

Adachi Medicine Professional Corporation, Hamilton, Canada

Status

Recruiting

Address

Adachi Medicine Professional Corporation

Hamilton, , L8N 1Y2

Credit Valley Rheumatology, Mississauga, Canada

Status

Recruiting

Address

Credit Valley Rheumatology

Mississauga, , L5M 2V8

Montreal, Canada

Status

Recruiting

Address

Institut de Recherche en Rhumatologie de Montréal

Montreal, , H2L 1S6

Montreal, Canada

Status

Recruiting

Address

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

Montreal, , H4A 3T2

Brent Appleton Clinic New Westminster, New Westminster, Canada

Status

Not yet recruiting

Address

Brent Appleton Clinic New Westminster

New Westminster, , V6Z 2C7

Oakville, Canada

Status

Recruiting

Address

Dr. A. M. Jaroszynska Rheumatology and Osteoporosis Clinic

Oakville, , L6M 4J2

Drs M&W Teo, Penticton, Canada

Status

Recruiting

Address

Drs M&W Teo

Penticton, , V2A 4Z1

Quebec, Canada

Status

Recruiting

Address

Groupe de recherche en maladies osseuses Inc.

Quebec, , G1V 3M7

Rimouski, Canada

Status

Recruiting

Address

Centre de Rhumatologie de l'Est du Quebec

Rimouski, , G5L 8W1

Polmed Research Inc., Saskatoon, Canada

Status

Recruiting

Address

Polmed Research Inc.

Saskatoon, , S7N 4A4

Clinique Jacques Cartier, Sherbrooke, Canada

Status

Recruiting

Address

Clinique Jacques Cartier

Sherbrooke, , J1J 2E3

St. Clare's Mercy Hospital, St John's, Canada

Status

Recruiting

Address

St. Clare's Mercy Hospital

St John's, , A1A 5B8

Dr. Juris Lazovskis Incorporated, Sydney, Canada

Status

Not yet recruiting

Address

Dr. Juris Lazovskis Incorporated

Sydney, , B1S 3N1

Toronto, Canada

Status

Not yet recruiting

Address

Toronto Western Hospital, University Health Network

Toronto, , M5T 2S8

Toronto, Canada

Status

Recruiting

Address

Arthur Karasik Medicine Professional Inc.

Toronto, , M9C 5N2

Dr. Jonathan D. Chan Inc., Vancouver, Canada

Status

Recruiting

Address

Dr. Jonathan D. Chan Inc.

Vancouver, , V5Z 1J9

Windsor, Canada

Status

Recruiting

Address

Dr. Sabeen Anwar Medicine Professional Corporation

Windsor, , N8X 5A6

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