Clinical trial NCT04826536: A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan
Official title: Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Japan
Observational
Psoriasis
Retrospective
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 participants, from 2 to 4 institutes which have a central role of psoriasis therapy in Japan, will be entered into the study if they started systemic treatment after 01/01/2017 and followed until either 12/31/2020, death, or lost to follow-up, whichever occurs first.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of participant background at first visit: Age
timeFrame: At Baseline
measure: Distribution of participant background at first visit: Sex
timeFrame: At Baseline
measure: Distribution of participant background at first visit: Duration with psoriasis
timeFrame: At Baseline
measure: Distribution of participant background at first visit: Comorbidities
timeFrame: At Baseline
measure: Distribution of participant background at first visit: Current status of phototherapy
timeFrame: At Baseline
measure: Treatment patterns: Drug names treated during study period
timeFrame: Up to 4 years
measure: Treatment patterns: Drug categories treated during study period
timeFrame: Up to 4 years
measure: Treatment patterns: Number of treatment changes during study period
timeFrame: Up to 4 years
measure: Treatment patterns: Treatment duration of each drug during study period
timeFrame: Up to 4 years
measure: Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period
timeFrame: Up to 4 years
measure: Treatment patterns: Adverse event (AE) at time of withdrawal of some drug
timeFrame: Up to 4 years
measure: Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal
timeFrame: Up to 4 years
measure: Treatment patterns: PASI at time of start of a new drug
timeFrame: Up to 4 years
measure: Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug
timeFrame: Up to 4 years
measure: Treatment patterns: Reason for treatment change during study period
timeFrame: Up to 4 years
measure: Treatment patterns: Status of phototherapy combination with systemic treatment
timeFrame: Up to 4 years
Secondary outcomes:
measure: Distribution of comorbidities that affect treatment choice and change
timeFrame: Up to 4 years
measure: Distribution of AEs that affect treatment choice and change
timeFrame: Up to 4 years
measure: Mean number of drug changes until participants achieve PASI 75 during study period
timeFrame: Up to 4 years
measure: Mean number of drug changes until participants achieve PASI 90 during study period
timeFrame: Up to 4 years
measure: Mean number of drug changes until participants achieve PASI 100 during study period
timeFrame: Up to 4 years
measure: Total period until participants achieve PASI 75 during study period
timeFrame: Up to 4 years
measure: Total period until participants achieve PASI 90 during study period
timeFrame: Up to 4 years
measure: Total period until participants achieve PASI 100 during study period
timeFrame: Up to 4 years
measure: Mean period of participants achieve PASI 75 by each systemic treatment
timeFrame: Up to 4 years
measure: Mean period of participants achieve PASI 90 by each systemic treatment
timeFrame: Up to 4 years
measure: Mean period of participants achieve PASI 100 by each systemic treatment
timeFrame: Up to 4 years
measure: Description of relationship between the reasons for treatment change and period of withdrawal
timeFrame: Up to 4 years
measure: Efficacy after re-start treatment measured by PASI
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: