Back to results

Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis

Primary Purpose

Psoriasis Vulgaris

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Peripheral blood samples were obtained following the standard procedures.

About this trial

This is an interventional diagnostic trial for Psoriasis Vulgaris focused on measuring NF-κB translocation, Lymphocytes, Flow cytometry with imaging (Amnis), Biological drugs, Сhildren and adolescents

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age from 1 to 18 years old
Mild, moderate, and severe psoriasis
Healthy children, as a comparison group
Patients receiving basic and external therapy, receiving systemic therapy with methotrexate and patients receiving therapy with biological drugs (Adalimumab, Etanercept, Ustekinumab)
A signed and dated informed consent received from the patient's parents (guardians), as well as from a patient over 14 years of age, to participate in the study
Ability to attend control visits within the specified time frame

Exclusion Criteria:

The presence of other concomitant skin diseases in the present or in the past, which could affect the assessment of the effect of the study drugs on the course of psoriasis
Use of other genetically engineered biological preparations in therapy
Participation in other clinical trials
Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out
Immunodeficiency disease
The presence in the past or present of any serious and / or unstable concomitant disease
The course of a viral, bacterial, fungal or parasitic infection

Sites / Locations

National Medical Research Center for Children's Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group

Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy

Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics

Arm Description

The analysis of the relative count of cells with NF-κB translocation in the lymphocyte populations the group of patients with psoriasis and in the comparison group.

Determination of the level of NF-kB translocation in lymphocyte populations in patient groups depending on the type of therapy: Group 1 - patients receiving basic and external therapy; Group 2 - patients receiving methotrexate; and Group 3 - patients receiving therapy with biological drugs.

Assessment of the level of NF-kB translocation in lymphocyte populations, assessment of PASI and BSA, assessment of the effectiveness of biological drugs in patients with psoriasis. Identification of patients in the stage of regression of the disease and in the progressive stage.

Outcomes

Primary Outcome Measures

The level of NF-kB translocation in lymphocyte populations

Changes in NF-kB translocation in lymphocyte populations

Patient age

Age assessment

PASI (Psoriasis Area Severity Index)

Change of the PASI

BSA (Body Surface Area)

Assessment of the affected area of the patient's body

Secondary Outcome Measures

Full Information

NCT ID

NCT04989296

First Posted

July 26, 2021

Last Updated

August 3, 2021

Sponsor

National Medical Research Center for Children's Health, Russian Federation

1. Study Identification

Unique Protocol Identification Number

NCT04989296

Brief Title

Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis

Official Title

Informative Value of Determining the Level of NF-κB Translocation by Flow Cytometry With Visualization in Lymphocyte Populations in Children With Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

November 20, 2019 (Actual)

Study Completion Date

January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Medical Research Center for Children's Health, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is the first to quantify the level of NF-kB translocation in lymphocyte populations in children and adolescents with psoriasis of varying severity.

Detailed Description

This is a diagnostic study aimed at finding immunological predictors of the effectiveness of therapy in children and adolescents with psoriasis. The study included 90 patients from 1 to 18 years old with psoriasis vulgaris, mild / moderate and severe. The comparison group consisted of 30 healthy children. The study took into account the PASI (Psoriasis Area Severity Index); the BSA (Body Surface Area); including patient age; duration of the disease; type of therapy; duration of therapy. Depending on the type of therapy, all psoriatic children were divided into 3 groups: Group 1 (n = 24) - patients receiving basic and external therapy; Group 2 (n = 20) - patients receiving systemic therapy with methotrexate; and Group 3 (n = 46) - patients receiving therapy with genetically engineered biological drugs (Adalimumab, Etanercept, Ustekinumab). The analysis of the NF-κB translocation level in lymphocytes was performed by flow cytometry with imaging (Image Stream Mark II - AMNIS) using the Amnis NF-κB Translocation Kit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

Keywords

NF-κB translocation, Lymphocytes, Flow cytometry with imaging (Amnis), Biological drugs, Сhildren and adolescents

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group

Arm Type

Experimental

Arm Description

The analysis of the relative count of cells with NF-κB translocation in the lymphocyte populations the group of patients with psoriasis and in the comparison group.

Arm Title

Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy

Arm Type

Experimental

Arm Description

Arm Title

Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Peripheral blood samples were obtained following the standard procedures.

Intervention Description

Taking 4 ml of peripheral blood from patients on an empty stomach.

Primary Outcome Measure Information:

Title

The level of NF-kB translocation in lymphocyte populations

Description

Changes in NF-kB translocation in lymphocyte populations

Time Frame

Screening on the 1 day of blood sampling

Title

Patient age

Description

Age assessment

Time Frame

from 1 to 18 years old

Title

PASI (Psoriasis Area Severity Index)

Description

Change of the PASI

Time Frame

1 day Screening at the time of examination

Title

BSA (Body Surface Area)

Description

Assessment of the affected area of the patient's body

Time Frame

1 day Screening at the time of examination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age from 1 to 18 years old Mild, moderate, and severe psoriasis Healthy children, as a comparison group Patients receiving basic and external therapy, receiving systemic therapy with methotrexate and patients receiving therapy with biological drugs (Adalimumab, Etanercept, Ustekinumab) A signed and dated informed consent received from the patient's parents (guardians), as well as from a patient over 14 years of age, to participate in the study Ability to attend control visits within the specified time frame Exclusion Criteria: The presence of other concomitant skin diseases in the present or in the past, which could affect the assessment of the effect of the study drugs on the course of psoriasis Use of other genetically engineered biological preparations in therapy Participation in other clinical trials Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out Immunodeficiency disease The presence in the past or present of any serious and / or unstable concomitant disease The course of a viral, bacterial, fungal or parasitic infection

Facility Information:

Facility Name

National Medical Research Center for Children's Health

City

Moscow

ZIP/Postal Code

119296

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis

We'll reach out to this number within 24 hrs