NCT04915105

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

June 7, 2021

Status Verified

May 1, 2021

Enrollment Period

4 years

First QC Date

May 31, 2021

Last Update Submit

May 31, 2021

Conditions

Dermatologic Disease

Keywords

PSO, PSA, SLE, PBMC

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • CRP

    3-6 months

  • DLQI

    6 months

Study Arms (1)

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

Markers data from PBMCsDIAGNOSTIC_TEST

Prescreen markers from patient individual PBMCs treating with streptococcus and different biologics.

Prescreen on psoriasis and psoriatic arthritis treatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin DiseasesSalivary Gland Adenoma, PleomorphicLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Chung-Yang Yen, MDPhD

    Attending Physician

    STUDY CHAIR

Central Study Contacts

Chung-Yang Yen, MDPhD

CONTACT

886423592525vernayen@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 7, 2021

Study Start

May 31, 2021

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

June 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share