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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05065762
Other study ID # IM011-174
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date February 7, 2022

Study information

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

Clinical Trial Summary

The purpose of this observational study is to identify and weight the treatment attributes from the moderate-to-severe Psoriasis (PsO) patients' perspective in Japan.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date February 7, 2022
Est. primary completion date February 7, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Diagnosis of moderate-to-severe Psoriasis (PsO) by physician (phase 1) or self-reported (phase 2) - Currently taking systemic psoriasis treatment - Japanese resident aged 20 years and older Exclusion Criteria: - Unable or unwilling to provide informed consent - Diagnosis of guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Local Institution Morrisville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psoriasis (PsO) patient preferences of moderate-to-severe systemic treatment atrribute Within 60 minutes of survey/interview
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 1: Sex At Baseline
Primary Distribution of socio-demographic characteristics of PsO participants in Phase 1: Age At Baseline
Primary Distribution of clinical characteristics of PsO participants in Phase 1: Time since PsO diagnosis At Baseline
Primary Distribution of clinical characteristics of PsO participants in Phase 1: Severity of PsO At Baseline
Primary Distribution of clinical characteristics of PsO participants in Phase 1: Current treatments for PsO At Baseline
Primary Distribution of clinical characteristics of PsO participants in Phase 1: Time on current PsO treatment At Baseline
Primary Distribution of socio-demographic characteristics of PsO participants in Phase 1: Residence At Baseline
Primary Distribution of socio-demographic characteristics of PsO participants in Phase 1: Employment status At Baseline
Primary Distribution of socio-demographic characteristics of PsO participants in Phase 1: Education At Baseline
Primary Distribution of clinical characteristics of PsO participants in Phase 1: Total number of previous treatments At Baseline
Primary Distribution of clinical characteristics of PsO participants in Phase 1: Previous treatments for PsO At Baseline
Primary Distribution of socio-demographic characteristics of PsO participants in Phase 1: Level of income At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Sex At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Age At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Height At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Weight At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Residence At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Employment status At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Type of occupation At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Education At Baseline
Primary Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time since PsO diagnosis At Baseline
Primary Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Self-reported severity At Baseline
Primary Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Current treatments for PsO At Baseline
Primary Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Time on current PsO treatment At Baseline
Primary Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Previous treatments for PsO At Baseline
Primary Distribution of clinical characteristics of Psoriasis (PsO) participants in Phase 2: Comorbid conditions of interest At Baseline
Primary Distribution of socio-demographic characteristics of Psoriasis (PsO) participants in Phase 2: Level of income At Baseline
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