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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04915105
Other study ID # CE20043B
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 31, 2021
Est. completion date May 31, 2025

Study information

Verified date May 2021
Source Taichung Veterans General Hospital
Contact Chung-Yang Yen, MDPhD
Phone 886423592525
Email vernayen@yahoo.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Markers data from PBMCs
Prescreen markers from patient individual PBMCs treating with streptococcus and different biologics.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary PASI score Psoriasis skin condition and severity 2 weeks to 3 months
Primary swelling joint count and tenderness joint count PSA severity 2 weeks to 3 months
Secondary CRP blood test 3-6 months
Secondary DLQI paper to investigate patient life quality 6 months
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