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

NCT04826536 | Completed

• 1 other identifier: IM011-166
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Japan; Observational; Psoriasis; Retrospective

Outcome Measures

Primary Outcomes (16)

• Distribution of participant background at first visit: Age

  At Baseline

• Distribution of participant background at first visit: Sex

  At Baseline

• Distribution of participant background at first visit: Duration with psoriasis

  At Baseline

• Distribution of participant background at first visit: Comorbidities

  At Baseline

• Distribution of participant background at first visit: Current status of phototherapy

  At Baseline

• Treatment patterns: Drug names treated during study period

  Up to 4 years

• Treatment patterns: Drug categories treated during study period

  Up to 4 years

• Treatment patterns: Number of treatment changes during study period

  Up to 4 years

• Treatment patterns: Treatment duration of each drug during study period

  Up to 4 years

• Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period

  Up to 4 years

• Treatment patterns: Adverse event (AE) at time of withdrawal of some drug

  Up to 4 years

• Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal

  Up to 4 years

• Treatment patterns: PASI at time of start of a new drug

  Up to 4 years

• Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug

  Up to 4 years

• Treatment patterns: Reason for treatment change during study period

  Up to 4 years

• Treatment patterns: Status of phototherapy combination with systemic treatment

  Up to 4 years

Secondary Outcomes (13)

• Distribution of comorbidities that affect treatment choice and change

  Up to 4 years

• Distribution of AEs that affect treatment choice and change

  Up to 4 years

• Mean number of drug changes until participants achieve PASI 75 during study period

  Up to 4 years

• Mean number of drug changes until participants achieve PASI 90 during study period

  Up to 4 years

• Mean number of drug changes until participants achieve PASI 100 during study period

  Up to 4 years

Study Arms (1)

Cohort 1

Participants with psoriasis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Minato-ku, Tokyo, 1070052, Japan

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 1, 2021
• Study Start: June 25, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

JP (1)