A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan

Psoriasis Clinical Trial

Official title:

Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826536
• Other study ID #: IM011-166
• Status: Completed
• Start date: June 25, 2021
• Est. completion date: October 8, 2021

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of psoriasis
• Can be followed for at least 2 years
• Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate

Exclusion Criteria:

• Enrolled in any clinical trials for psoriasis in their follow-up period
• Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date
• Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Japan	Local Institution	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of participant background at first visit: Age		At Baseline
Primary	Distribution of participant background at first visit: Sex		At Baseline
Primary	Distribution of participant background at first visit: Duration with psoriasis		At Baseline
Primary	Distribution of participant background at first visit: Comorbidities		At Baseline
Primary	Distribution of participant background at first visit: Current status of phototherapy		At Baseline
Primary	Treatment patterns: Drug names treated during study period		Up to 4 years
Primary	Treatment patterns: Drug categories treated during study period		Up to 4 years
Primary	Treatment patterns: Number of treatment changes during study period		Up to 4 years
Primary	Treatment patterns: Treatment duration of each drug during study period		Up to 4 years
Primary	Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period		Up to 4 years
Primary	Treatment patterns: Adverse event (AE) at time of withdrawal of some drug		Up to 4 years
Primary	Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal		Up to 4 years
Primary	Treatment patterns: PASI at time of start of a new drug		Up to 4 years
Primary	Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug		Up to 4 years
Primary	Treatment patterns: Reason for treatment change during study period		Up to 4 years
Primary	Treatment patterns: Status of phototherapy combination with systemic treatment		Up to 4 years
Secondary	Distribution of comorbidities that affect treatment choice and change		Up to 4 years
Secondary	Distribution of AEs that affect treatment choice and change		Up to 4 years
Secondary	Mean number of drug changes until participants achieve PASI 75 during study period	75% reduction in the Psoriasis Area and Severity Index score (PASI 75)	Up to 4 years
Secondary	Mean number of drug changes until participants achieve PASI 90 during study period	90% reduction in the Psoriasis Area and Severity Index score (PASI 90)	Up to 4 years
Secondary	Mean number of drug changes until participants achieve PASI 100 during study period	100% reduction in the Psoriasis Area and Severity Index score (PASI 100)	Up to 4 years
Secondary	Total period until participants achieve PASI 75 during study period		Up to 4 years
Secondary	Total period until participants achieve PASI 90 during study period		Up to 4 years
Secondary	Total period until participants achieve PASI 100 during study period		Up to 4 years
Secondary	Mean period of participants achieve PASI 75 by each systemic treatment		Up to 4 years
Secondary	Mean period of participants achieve PASI 90 by each systemic treatment		Up to 4 years
Secondary	Mean period of participants achieve PASI 100 by each systemic treatment		Up to 4 years
Secondary	Description of relationship between the reasons for treatment change and period of withdrawal		Up to 4 years
Secondary	Efficacy after re-start treatment measured by PASI		Up to 4 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls