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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Diagnostic test: Peripheral blood samples were obtained following the standard procedures.

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119296
    • National Medical Research Center for Children's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age from 1 to 18 years old
2. Mild, moderate, and severe psoriasis
3. Healthy children, as a comparison group
4. Patients receiving basic and external therapy, receiving systemic therapy with methotrexate and patients receiving therapy with biological drugs (Adalimumab, Etanercept, Ustekinumab)
5. 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
6. Ability to attend control visits within the specified time frame

Exclusion Criteria:

1. 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
2. Use of other genetically engineered biological preparations in therapy
3. Participation in other clinical trials
4. Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out
5. Immunodeficiency disease
6. The presence in the past or present of any serious and / or unstable concomitant disease
7. The course of a viral, bacterial, fungal or parasitic infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group; 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.	Diagnostic test: Peripheral blood samples were obtained following the standard procedures.; Taking 4 ml of peripheral blood from patients on an empty stomach.
Experimental: Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy; 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.	Diagnostic test: Peripheral blood samples were obtained following the standard procedures.; Taking 4 ml of peripheral blood from patients on an empty stomach.
Experimental: Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics; 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.	Diagnostic test: Peripheral blood samples were obtained following the standard procedures.; Taking 4 ml of peripheral blood from patients on an empty stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of NF-kB translocation in lymphocyte populations	Changes in NF-kB translocation in lymphocyte populations	Screening on the 1 day of blood sampling
Patient age	Age assessment	from 1 to 18 years old
PASI (Psoriasis Area Severity Index)	Change of the PASI	1 day Screening at the time of examination
BSA (Body Surface Area)	Assessment of the affected area of the patient's body	1 day Screening at the time of examination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Lymphocytes; NF-κB translocation; Flow cytometry with imaging (Amnis); Biological drugs; Сhildren and adolescents
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 05912657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No