Dermatologic DiseaseNCT04915105
Personal Precise Treatment on Psoriasis and Psoriatic Arthritis
A study testing Markers data from PBMCs in people with Dermatologic Disease, run by Taichung Veterans General Hospital.
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 Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatologic Disease
- What is being tested?
- Markers data from PBMCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2021to 31 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- nil
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Personal Precise Treatment on Psoriasis and Psoriatic Arthritis and Investigate the Mechanisms of Biological Agents Induced Systemic Lupus Erythematosus
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
Read the 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.
- Conditions
- Dermatologic Disease
- Being tested
- Markers data from PBMCs
- Keywords
- PSO, PSA, SLE, PBMC
- Medical subject headings
- Skin Diseases, Salivary Gland Adenoma, Pleomorphic, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Markers data from PBMCsDiagnostic test
Prescreen markers from patient individual PBMCs treating with streptococcus and different biologics.
| Study group | Role | What they receive |
|---|---|---|
| Prescreen on psoriasis and psoriatic arthritis treatment | Experimental | Prescreen markers from individual PBMCs and choose proper biologics before starting treatment on psoriasis and psoriatic arthritis patients. Receives: Diagnostic Test: Markers data from PBMCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI score
Psoriasis skin condition and severity
Measured: 2 weeks to 3 months
swelling joint count and tenderness joint count
PSA severity
Measured: 2 weeks to 3 months
Secondary outcomes (2)
CRP
blood test
Measured: 3-6 months
DLQI
paper to investigate patient life quality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start31 May 2021 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung-Yang Yen, MDPhD, Study chair, Attending Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915105
- Sponsor's protocol ID
- CE20043B
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No