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Personal Precise Treatment on Psoriasis and Psoriatic Arthritis

Primary Purpose

Dermatologic Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Markers data from PBMCs
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dermatologic Disease focused on measuring PSO, PSA, SLE, PBMC

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. Healthy control without underline disease such as psoriasis and psoriatic arthritis. 2. Psoriasis been diagnosed for over six months and PASI >10. 3.Psoriatic arthritis been diagnosed for over six months and >1 swallow and tender joints

Exclusion Criteria:

  • nil

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Prescreen on psoriasis and psoriatic arthritis treatment

    Arm Description

    Prescreen markers from individual PBMCs and choose proper biologics before starting treatment on psoriasis and psoriatic arthritis patients.

    Outcomes

    Primary Outcome Measures

    PASI score
    Psoriasis skin condition and severity
    swelling joint count and tenderness joint count
    PSA severity

    Secondary Outcome Measures

    CRP
    blood test
    DLQI
    paper to investigate patient life quality

    Full Information

    First Posted
    May 31, 2021
    Last Updated
    May 31, 2021
    Sponsor
    Taichung Veterans General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04915105
    Brief Title
    Personal Precise Treatment on Psoriasis and Psoriatic Arthritis
    Official Title
    Personal Precise Treatment on Psoriasis and Psoriatic Arthritis and Investigate the Mechanisms of Biological Agents Induced Systemic Lupus Erythematosus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 31, 2021 (Anticipated)
    Primary Completion Date
    May 31, 2025 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taichung Veterans General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Part of psoriasis and psoriatic arthritis patients treated with biologics and met primary failure. Therefore, we are going to create a cell based platform to evaluate the treatment effects of different biologics on psoriasis and psoriatic arthritis patients before prescribed by physicians
    Detailed Description
    PBMCs isolated from psoriasis and psoriatic arthritis and incubated with Group A streptococcus and different biologics for 24 hours. Cytokines expression in the culture supernatants will be measured and the data can be reference for physician's prescription.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dermatologic Disease
    Keywords
    PSO, PSA, SLE, PBMC

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prescreen on psoriasis and psoriatic arthritis treatment
    Arm Type
    Experimental
    Arm Description
    Prescreen markers from individual PBMCs and choose proper biologics before starting treatment on psoriasis and psoriatic arthritis patients.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Markers data from PBMCs
    Intervention Description
    Prescreen markers from patient individual PBMCs treating with streptococcus and different biologics.
    Primary Outcome Measure Information:
    Title
    PASI score
    Description
    Psoriasis skin condition and severity
    Time Frame
    2 weeks to 3 months
    Title
    swelling joint count and tenderness joint count
    Description
    PSA severity
    Time Frame
    2 weeks to 3 months
    Secondary Outcome Measure Information:
    Title
    CRP
    Description
    blood test
    Time Frame
    3-6 months
    Title
    DLQI
    Description
    paper to investigate patient life quality
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1. Healthy control without underline disease such as psoriasis and psoriatic arthritis. 2. Psoriasis been diagnosed for over six months and PASI >10. 3.Psoriatic arthritis been diagnosed for over six months and >1 swallow and tender joints Exclusion Criteria: nil
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chung-Yang Yen, MDPhD
    Phone
    886423592525
    Ext
    5304
    Email
    vernayen@yahoo.com.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chung-Yang Yen, MDPhD
    Organizational Affiliation
    Attending Physician
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Personal Precise Treatment on Psoriasis and Psoriatic Arthritis

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