Psoriatic Arthritis and Psoriasis Treatment Decision Aid

Study Purpose

The purpose of this study is to create and test a patient decision aid that facilitates the shared decision-making process when patients with psoriasis and/or psoriatic arthritis are starting or switching to a new therapy.

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.

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

Inclusion Criteria:

1. Age 18 years or older. 2. Diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist) 3. Treated at Penn. In addition to the above, for the observation and implementation phases of the study: 4. Initiation of a new psoriasis or psoriatic arthritis treatment.
  • - Biosimilars that have been approved by the FDA and available on the US market will similarly be eligible for participation.
  • - Patients may be taking other traditional DMARDs.
  • - A washout period is not required.

Exclusion Criteria:

1. Unable to give informed consent. 2. Youth, under the age of 18 years. 3. Patients without psoriasis or psoriatic arthritis. 4. Not being treated at a Penn clinic. In addition to the above, for the observation and implementation phases of the study: 5. Not starting or switching to a new medication

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.

NCT03737045
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.

N/A
Lead Sponsor

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

University of Pennsylvania
Principal Investigator

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

Alexis Ogdie-Beatty, MD
Principal Investigator Affiliation University of Pennsylvania
Agency Class

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

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

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

Psoriatic Arthritis, Psoriasis
Additional Details

Prior to the interventional study, we will develop a decision aid using design thinking. In this interventional study, we will implement and test a patient-centered decision aid for therapy selection among patients with psoriasis and/or psoriatic arthritis who are starting or switching to a new medication.

Arms & Interventions

Arms

Other: Decision Aid Testing

Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.

Interventions

Other: - Decision Aid

Participants will test decision aid prototypes that are designed to assist them in choosing a medication.

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.

Philadelphia, Pennsylvania

Status

Recruiting

Address

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Kathleen Bush, BS

katbu@upenn.edu

215-662-6332

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