Juvenile Idiopathic ArthritisNCT07000916
Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults
An observational study of Juvenile Idiopathic Arthritis and Rheumatoid Arthritis, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Population: Juvenile idiopathic arthritis (JIA), rheumatoid arthritis (RA) and seronegative / psoriatic / undifferentiated arthritis (UA), systemic lupus erythematosus (SLE) or diffuse systemic sclerosis dSS). Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA. Read more about this study
- Who is it for?
- Ages 2 to 50 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Psoriatic Arthritis
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Sep 2013to 31 Mar 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with juvenile idiopathic arthritis, rheumatoid arthritis and seronegative / psoriatic / undifferentiated arthritis, systemic lupus erythematosus or diffuse systemic sclerosis
Who may be able to join
- Diagnosis of juvenile idiopathic arthritis, rheumatoid arthritis and seronegative / psoriatic / undifferentiated arthritis, systemic lupus erythematosus or diffuse systemic sclerosis (ACR criteria).
- Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA.
Who cannot join
- Treated for > 3 months
- > 50 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UCLouvain
Brussels, 1200
Patrick Durez, patrick.durez@uclouvain.be
Tatiana Sokolova, tatiana.sokolova@uclouvain.be
About this study
Official title: Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults. Optimization of Clinical Response, Remission, Quality of Life and Analysis of Prognostic Markers
Population:
Juvenile idiopathic arthritis (JIA), rheumatoid arthritis (RA) and seronegative / psoriatic / undifferentiated arthritis (UA), systemic lupus erythematosus (SLE) or diffuse systemic sclerosis dSS).
Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA.
These 5 cohorts will be subject to standardized clinical monitoring.
Read the detailed description
This study is proposed by the Rheumatology and Pediatrics departments of the 3 French-speaking Universities.
The first objective will be to include a progressive number of new young patients (≤ 50 years) in order to optimize and standardize care and clinical response objectives. The number of 25% of new incident cases will be sought with an increase of 20% each year during the 5 to 10 years of this project.
Population: JIA, RA/UA, SLE, dSS (American Congres of Rheumatology criteria). Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA.
These 5 cohorts will be subject to standardized clinical monitoring and specific objectives that will make it possible to analyze the number of patients with a good control of the disease and/or a clinical remission, defined according to the international criteria.
- Conditions
- Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus, Diffuse Systemic Sclerosis, Seronegative Arthritis
- Medical subject headings
- Arthritis, Juvenile, Arthritis, Rheumatoid, Arthritis, Psoriatic, Lupus Erythematosus, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| juvenile idiopathic arthritis (JIA) | aged <= 16 y.o. recent diagnosis of JIA and DMARDs treatment-naive patients; aged <18 y.o. recent diagnosis of JIA | |
| rheumatoid arthritis (RA) | aged =>18; =< 50 y.o. recent diagnosis of RA and DMARDs treatment-naive patients | |
| diffuse systemic sclerosis (dSS) | aged =>18; =< 50 y.o. recent diagnosis of dSS and DMARDs treatment-naive patients | |
| seronegative arthritis (UA) | aged =>18; =< 50 y.o. recent diagnosis of UA and DMARDs treatment-naive patients | |
| systemic lupus erythematosus (SLE) | aged =>18; =< 50 y.o. recent diagnosis of SLE and DMARDs treatment-naive patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate or absence of synovitis in Rheumatoid arthritis patients
Measured: Through the entire study, during approximately 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start11 Sep 2013
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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 Université Catholique de LouvainThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Durez, Pr, Study director, UCLouvain - IREC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000916
- Sponsor's protocol ID
- Cap 48 polyarthrite
- Status last verified
- May 2025
- First submitted
- 25 Apr 2019
- Last updated
- 3 Jun 2025
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults. Optimization of Clinical Response, Remission, Quality of Life and Analysis of Prognostic Markers
- ClinicalTrials.gov ID
- NCT07000916
- Acronym / sponsor ID
- Cap 48 polyarthrite
- Conditions
- Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus, Diffuse Systemic Sclerosis, Seronegative Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 11 Sep 2013 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Jun 2025 (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.
Population:
Juvenile idiopathic arthritis (JIA), rheumatoid arthritis (RA) and seronegative / psoriatic / undifferentiated arthritis (UA), systemic lupus erythematosus (SLE) or diffuse systemic sclerosis dSS).
Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA.
These 5 cohorts will be subject to standardized clinical monitoring.
Detailed description
This study is proposed by the Rheumatology and Pediatrics departments of the 3 French-speaking Universities.
The first objective will be to include a progressive number of new young patients (≤ 50 years) in order to optimize and standardize care and clinical response objectives. The number of 25% of new incident cases will be sought with an increase of 20% each year during the 5 to 10 years of this project.
Population: JIA, RA/UA, SLE, dSS (American Congres of Rheumatology criteria). Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA.
These 5 cohorts will be subject to standardized clinical monitoring and specific objectives that will make it possible to analyze the number of patients with a good control of the disease and/or a clinical remission, defined according to the international criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| juvenile idiopathic arthritis (JIA) | – | –aged <= 16 y.o. recent diagnosis of JIA and DMARDs treatment-naive patients; aged <18 y.o. recent diagnosis of JIA |
| rheumatoid arthritis (RA) | – | –aged =>18; =< 50 y.o. recent diagnosis of RA and DMARDs treatment-naive patients |
| diffuse systemic sclerosis (dSS) | – | –aged =>18; =< 50 y.o. recent diagnosis of dSS and DMARDs treatment-naive patients |
| seronegative arthritis (UA) | – | –aged =>18; =< 50 y.o. recent diagnosis of UA and DMARDs treatment-naive patients |
| systemic lupus erythematosus (SLE) | – | –aged =>18; =< 50 y.o. recent diagnosis of SLE and DMARDs treatment-naive patients |
Who may qualify
- Ages
- 2 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with juvenile idiopathic arthritis, rheumatoid arthritis and seronegative / psoriatic / undifferentiated arthritis, systemic lupus erythematosus or diffuse systemic sclerosis
Key inclusion criteria (2 listed)
- Diagnosis of juvenile idiopathic arthritis, rheumatoid arthritis and seronegative / psoriatic / undifferentiated arthritis, systemic lupus erythematosus or diffuse systemic sclerosis (ACR criteria).
- Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA.
Key exclusion criteria (2 listed)
- Treated for > 3 months
- > 50 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Remission rate or absence of synovitis in Rheumatoid arthritis patients
Time frame: Through the entire study, during approximately 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- 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.
Patrick Durez, Pr study director
UCLouvain - IREC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and Rheumatoid Arthritis, run by Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Durez (+32 02 764 53 89, patrick.durez@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate or absence of synovitis in Rheumatoid arthritis patients (time frame: Through the entire study, during approximately 15 years). 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 3 Jun 2025.