Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03737045
Other study ID # 831515
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Hospital at the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey Satisfaction survey to rate the decision aid and shared decision-making process Up to 24 months
Secondary Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment. Rates of of the decision aid use Up to 24 months
See also
  Status Clinical Trial Phase
Completed NCT03236870 - A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Completed NCT00078819 - Etanercept (Enbrel®) in Psoriasis - Pediatrics Phase 3
Completed NCT04841187 - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting NCT03927352 - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis Phase 3
Completed NCT03284879 - Post-Marketing Surveillance Study of OTEZLA
Recruiting NCT06027034 - Effectiveness of a Digital Health Application for Psoriasis N/A
Not yet recruiting NCT06050330 - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study N/A
Recruiting NCT05744466 - A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Completed NCT04149587 - A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Completed NCT01384630 - Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis Phase 2
Completed NCT03998683 - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis Phase 3
Terminated NCT03556202 - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3) Phase 3
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06077331 - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT04316585 - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants Phase 1
Completed NCT04894890 - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed NCT00358384 - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034 Phase 1
Completed NCT03757013 - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed NCT03265613 - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
Completed NCT05003531 - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis Phase 2