Juvenile Idiopathic ArthritisBDG -JIANCT03984669
(1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy
A study testing The Juvenile Disease Activity Score (JADAS) and (1-3)-ß-D-Glucan (BDG) assay (Fungitell) in people with Juvenile Idiopathic Arthritis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- The Juvenile Disease Activity Score (JADAS) and (1-3)-ß-D-Glucan (BDG) assay (Fungitell)
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients under the age of 18 years with JIA's disease
- followed at the CHU Amiens (French University hospital)
- signed parent consent form
Who cannot join
- lack of consent from parents or patient
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- The Juvenile Disease Activity Score (JADAS), (1-3)-ß-D-Glucan (BDG) assay (Fungitell)
- Keywords
- juvenile idiopathic arthritis, (1,3)-beta-D-glucan, children, inflammatory status, intestinal microbiota, activity od the disease
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Juvenile Disease Activity Score (JADAS)Diagnostic test
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.
(1-3)-ß-D-Glucan (BDG) assay (Fungitell)Biological
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis
(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.
Measured: one year
Secondary outcomes (1)
Correlation of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start11 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Djamal-Dine Djeddi, MD, Principal investigator, CHU AmiensTaieb Chouaki, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984669
- Sponsor's protocol ID
- PI2018_843_0036
- Acronym
- BDG -JIA
- Status last verified
- Jan 2023
- First submitted
- 11 Jun 2019
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy
- ClinicalTrials.gov ID
- NCT03984669
- Acronym / sponsor ID
- BDG -JIA / PI2018_843_0036
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- juvenile idiopathic arthritis, (1,3)-beta-D-glucan, children, inflammatory status, intestinal microbiota, activity od the disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All patients under the age of 18 years with JIA's disease
- followed at the CHU Amiens (French University hospital)
- signed parent consent form
Key exclusion criteria (1 listed)
- lack of consent from parents or patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | 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 | Biological | – |
Primary outcome
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.
1 secondary outcome
Correlation of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis score (JADAS)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamal-Dine Djeddi, MD principal investigator
CHU Amiens
Taieb Chouaki, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Juvenile Disease Activity Score (JADAS) and (1-3)-ß-D-Glucan (BDG) assay (Fungitell) in people with Juvenile Idiopathic Arthritis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.