Personal Precise Treatment on Psoriasis and Psoriatic Art... | NCT04915105

Studies
Personal Precise Treatment on Psoriasis and Psoriatic Arthritis

NCT04915105

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Jun 7, 2021Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Dermatologic Disease

Interventions

Markers data from PBMCs

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2021Estimated

Primary Completion Date

May 31, 2025Estimated

Completion Date

May 31, 2025Estimated

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

May 31, 2021

First Posted Date

Jun 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2021

Last Update Posted Date

Jun 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Diagnostic Test: Markers data from PBMCs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Markers data from PBMCs	Diagnostic Test	Prescreen markers from patient individual PBMCs treating with streptococcus and different biologics.	Prescreen on psoriasis and psoriatic arthritis treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PASI score	Psoriasis skin condition and severity	2 weeks to 3 months
swelling joint count and tenderness joint count	PSA severity	2 weeks to 3 months

Secondary Outcomes

Measure	Description	Time Frame
CRP	blood test	3-6 months
DLQI	paper to investigate patient life quality	6 months

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chung-Yang Yen, MDPhD	Contact	886423592525	5304	vernayen@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Chung-Yang Yen, MDPhD	Attending Physician	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012871	Skin Diseases
C563250	Salivary Gland Adenoma, Pleomorphic
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D017437	Skin and Connective Tissue Diseases
D003240	Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided