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
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.
- 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