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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNF-alpha inhibitor | Active Comparator |
| |
| Methotrexate | Active Comparator |
| |
| Healthy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine, Immune function | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab) | Analysing T and B cells (%, /microL) by flow cytometry. | 12-14 weeks |
| Immune response to influenza vaccine, the rate of seroconversion | Measuring seroconversion after influenza vaccine (IU) | 12-14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pécs, Medical School, Department of Paediatrics | Pécs | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33363071 | Derived | 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. |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D055633 | Immune System Phenomena |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |