The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary

NCT ID: NCT03833271

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-28

Study Completion Date

2019-09-30

Brief Summary

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The aim of our study is to compare the immune function of patient treated with DMARD (methotrexate), or tumor necrosis factor (TNF)-alpha inhibitor (adalimumab) to healthy children. The study consists of three parts. In each part physical examination and routine laboratory tests are done.

At the first examination flow cytometry analysis is performed, after that the participants are immunized with influenza (3Fluart) vaccine. At part two and three further flow cytometry is carried out and seroconversion is measured.

Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TNF-alpha inhibitor

Group Type ACTIVE_COMPARATOR

Influenza vaccine, Immune function

Intervention Type BIOLOGICAL

Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.

Methotrexate

Group Type ACTIVE_COMPARATOR

Influenza vaccine, Immune function

Intervention Type BIOLOGICAL

Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.

Healthy

Group Type ACTIVE_COMPARATOR

Influenza vaccine, Immune function

Intervention Type BIOLOGICAL

Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.

Interventions

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Influenza vaccine, Immune function

Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* JIA (oligoarticular, polyarticular) treated with MTX or MTX/adalimumab
* Healthy controls

Exclusion Criteria

* Children with infection
* Children with active JIA disease
* JIA other than oligoarticular, polyarticular type
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Nagy Arnold

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pécs, Medical School, Department of Paediatrics

Pécs, , Hungary

Site Status

Countries

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Hungary

References

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Nagy A, Mosdosi B, Simon D, Dergez T, Berki T. Peripheral Blood Lymphocyte Analysis in Oligo- and Polyarticular Juvenile Idiopathic Arthritis Patients Receiving Methotrexate or Adalimumab Therapy: A Cross-Sectional Study. Front Pediatr. 2020 Dec 10;8:614354. doi: 10.3389/fped.2020.614354. eCollection 2020.

Reference Type DERIVED
PMID: 33363071 (View on PubMed)

Other Identifiers

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MS Pecs-Paediatrics

Identifier Type: -

Identifier Source: org_study_id

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