Clinical trial NCT07000916: Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Juvenile Idiopathic Arthritis
Rheumatoid Arthritis
Psoriatic Arthritis
Systemic Lupus Erythematosus
Diffuse Systemic Sclerosis
Seronegative Arthritis
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with juvenile idiopathic arthritis, rheumatoid arthritis and seronegative / psoriatic / undifferentiated arthritis, systemic lupus erythematosus or diffuse systemic sclerosis

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Treated for \> 3 months
* \> 50 years old

Primary outcomes:
measure: Remission rate or absence of synovitis in Rheumatoid arthritis patients
timeFrame: Through the entire study, during approximately 15 years
Secondary outcomes:
Other outcomes:
measure: Remission rates improvement in Juvenile arthritis (JIA) patients
timeFrame: Through the entire study, during approximately 15 years
measure: Reduction in damage rate in Systemic Lupus Erythematosus patients
timeFrame: Through the entire study, during approximately 15 years
measure: Inclusion of at least 80% of the incident cases of diffuse Systemic sclerosis
timeFrame: Through the entire study, during approximately 15 years
Locations:
city: Brussels
country: Belgium
facility: UCLouvain
Study officials:
affiliation: UCLouvain - IREC
name: Patrick Durez, Pr
role: STUDY_DIRECTOR
References: