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
About this trial
This is an interventional screening trial for Dermatologic Disease focused on measuring PSO, PSA, SLE, PBMC
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
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
NCT ID
NCT04915105
First Posted
May 31, 2021
Last Updated
May 31, 2021
Sponsor
Taichung Veterans General Hospital
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
Learn more about this trial
Personal Precise Treatment on Psoriasis and Psoriatic Arthritis
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