- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984669
(1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy (BDG -JIA)
January 17, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis
Time Frame: one year
|
(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.
BDG assays (Fungitell®) will be performed on serum of each JIA patients.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis score (JADAS)
Time Frame: one year
|
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.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Djamal-Dine Djeddi, MD, CHU Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2019
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
June 11, 2019
First Submitted That Met QC Criteria
June 11, 2019
First Posted (Actual)
June 13, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2018_843_0036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Juvenile Idiopathic Arthritis
-
University of AarhusAarhus University HospitalCompletedPolyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, OligoarthritisDenmark
-
Institut National de la Santé Et de la Recherche...CompletedSystemic-Onset Juvenile Idiopathic ArthritisFrance
-
GeneScience Pharmaceuticals Co., Ltd.Not yet recruitingActive Systemic Juvenile Idiopathic ArthritisChina
-
Novartis PharmaceuticalsCompletedSystemic Juvenile Idiopathic Arthritis (SJIA)Italy, Russian Federation, Turkey, Belgium, Spain, Germany, France, Israel, Canada, United States, Hungary, Austria, Brazil, Sweden, Netherlands, Poland
-
Novartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompletedSystemic Juvenile Idiopathic Arthritis With Active FlareUnited States, Argentina, Canada, Switzerland, Germany, Israel, South Africa, Belgium, Italy, Spain, France, Brazil, Turkey, Hungary, Poland, Norway, Sweden, Netherlands, Peru
-
University of British ColumbiaUniversity of Manitoba; The Hospital for Sick Children; McGill University Health... and other collaboratorsRecruiting
-
AbbVieCompletedPolyarticular Juvenile Idiopathic Arthritis
-
NovartisCompletedArthritis, Juvenile RheumatoidItaly
-
Assistance Publique - Hôpitaux de ParisRecruitingJuvenile Idiopathic Arthritis (JIA)France
-
AbbVieRecruitingJuvenile Idiopathic Arthritis (JIA)United States, Germany, Hungary, Israel, Puerto Rico, Spain, Japan, Canada, Italy, Sweden
Clinical Trials on The Juvenile Disease Activity Score (JADAS)
-
Kutahya Health Sciences UniversityCompletedChronic Pain | Juvenile Idiopathic ArthritisTurkey
-
Assiut UniversityCompletedRheumatoid ArthritisEgypt
-
Bozyaka Training and Research HospitalRecruiting
-
University Hospital Inselspital, BerneUniversity of Colorado, Denver; Mayo Clinic; Northwestern University; University... and other collaboratorsUnknownDeglutition Disorders | Esophageal Diseases | EosinophiliaUnited States, Canada, Switzerland, United Kingdom
-
Afyonkarahisar Health Sciences UniversityRecruiting
-
NHS Greater Glasgow and ClydeWyeth is now a wholly owned subsidiary of Pfizer; University of Glasgow; Chief... and other collaboratorsUnknownRheumatoid Arthritis | PolyarthritisUnited Kingdom
-
Lille Catholic UniversityUniversite du Littoral Cote d'OpaleCompletedBiomarkers | Smokers | Human Bronchial Epithelial Cells | Lung Pathogenesis
-
University of Texas at AustinNational Institute of Nursing Research (NINR)Recruiting
-
Bezmialem Vakif UniversityCompleted
-
Alexandria UniversityCompletedDialysis; ComplicationsEgypt