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

NCT ID: NCT04989296

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-01-15

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.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Peripheral blood samples were obtained following the standard procedures.

Intervention Type: DIAGNOSTIC_TEST

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

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.

Group Type: EXPERIMENTAL

Peripheral blood samples were obtained following the standard procedures.

Intervention Type: DIAGNOSTIC_TEST

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

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.

Group Type: EXPERIMENTAL

Peripheral blood samples were obtained following the standard procedures.

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Peripheral blood samples were obtained following the standard procedures.

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Medical Research Center for Children's Health

Moscow, , Russia

Countries

Russia

Other Identifiers

05912657

Identifier Type: -

Identifier Source: org_study_id