(1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy

NCT ID: NCT03984669

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2020-06-01

Brief Summary

Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease of childhood. Most children still experience prolonged periods of active disease, however, there is still lack of effective and specific markers for early diagnosis of relapse. The pathogenesis of JIA is thought to be the result of a combination of host genetic and environmental triggers and The microbiota is a potential contributing factor to the development of the disease. (1-3)-ß-D-Glucan (BDG), a component of most fungal cell walls, possess immunomodulatory activities. Latest studies demonstrate that it acts as a trigger for autoimmune arthritis in adult. However the relation with JIA is not clearly defined. The objective of this study was to evaluate the (1,3)-Béta-D-Glucans level in patients with JIA and whether higher serum BDG levels are correlated with JIA activity of disease, comparatively with usual markers.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

The Juvenile Disease Activity Score (JADAS)

The JADAS includes the following four measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) where 0 = no activity and 10 = maximum activity; parent global assessment of well-being, measured on a 0-10 VAS where 0 = very well and 10 = very poor; the erythrocyte sedimentation rate (ESR), normalized to a 0 to 10 scale; and a count of joints with active disease.

Intervention Type: DIAGNOSTIC_TEST

(1-3)-ß-D-Glucan (BDG) assay (Fungitell)

Evaluation of the (1,3)-Beta-D-Glucans level in patients with JIA and correlation of the higher serum BDG levels with JIA activity of disease, comparatively with usual markers

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• All patients under the age of 18 years with JIA's disease
• followed at the CHU Amiens (French University hospital)
• signed parent consent form

Exclusion Criteria

• lack of consent from parents or patient

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Djamal-Dine Djeddi, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Taieb Chouaki, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, , France

Countries

France

Other Identifiers

PI2018_843_0036

Identifier Type: -

Identifier Source: org_study_id