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

2. juni 2022 opdateret af: Bristol-Myers Squibb

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

114

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1070052
        • Local Institution

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Cohort 1
Participants with psoriasis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Distribution of participant background at first visit: Age
Tidsramme: At Baseline
At Baseline
Distribution of participant background at first visit: Sex
Tidsramme: At Baseline
At Baseline
Distribution of participant background at first visit: Duration with psoriasis
Tidsramme: At Baseline
At Baseline
Distribution of participant background at first visit: Comorbidities
Tidsramme: At Baseline
At Baseline
Distribution of participant background at first visit: Current status of phototherapy
Tidsramme: At Baseline
At Baseline
Treatment patterns: Drug names treated during study period
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Drug categories treated during study period
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Number of treatment changes during study period
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Treatment duration of each drug during study period
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Adverse event (AE) at time of withdrawal of some drug
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: PASI at time of start of a new drug
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Reason for treatment change during study period
Tidsramme: Up to 4 years
Up to 4 years
Treatment patterns: Status of phototherapy combination with systemic treatment
Tidsramme: Up to 4 years
Up to 4 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distribution of comorbidities that affect treatment choice and change
Tidsramme: Up to 4 years
Up to 4 years
Distribution of AEs that affect treatment choice and change
Tidsramme: Up to 4 years
Up to 4 years
Mean number of drug changes until participants achieve PASI 75 during study period
Tidsramme: Up to 4 years
75% reduction in the Psoriasis Area and Severity Index score (PASI 75)
Up to 4 years
Mean number of drug changes until participants achieve PASI 90 during study period
Tidsramme: Up to 4 years
90% reduction in the Psoriasis Area and Severity Index score (PASI 90)
Up to 4 years
Mean number of drug changes until participants achieve PASI 100 during study period
Tidsramme: Up to 4 years
100% reduction in the Psoriasis Area and Severity Index score (PASI 100)
Up to 4 years
Total period until participants achieve PASI 75 during study period
Tidsramme: Up to 4 years
Up to 4 years
Total period until participants achieve PASI 90 during study period
Tidsramme: Up to 4 years
Up to 4 years
Total period until participants achieve PASI 100 during study period
Tidsramme: Up to 4 years
Up to 4 years
Mean period of participants achieve PASI 75 by each systemic treatment
Tidsramme: Up to 4 years
Up to 4 years
Mean period of participants achieve PASI 90 by each systemic treatment
Tidsramme: Up to 4 years
Up to 4 years
Mean period of participants achieve PASI 100 by each systemic treatment
Tidsramme: Up to 4 years
Up to 4 years
Description of relationship between the reasons for treatment change and period of withdrawal
Tidsramme: Up to 4 years
Up to 4 years
Efficacy after re-start treatment measured by PASI
Tidsramme: Up to 4 years
Up to 4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. juni 2021

Primær færdiggørelse (Faktiske)

8. oktober 2021

Studieafslutning (Faktiske)

8. oktober 2021

Datoer for studieregistrering

Først indsendt

31. marts 2021

Først indsendt, der opfyldte QC-kriterier

31. marts 2021

Først opslået (Faktiske)

1. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IM011-166

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Psoriasis

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kazakhstan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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