NCT07000916

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Sep 2013Mar 2028

Study Start

First participant enrolled

September 11, 2013

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
6.1 years until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

14.6 years

First QC Date

April 25, 2019

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Remission rate or absence of synovitis in Rheumatoid arthritis patients

    Through the entire study, during approximately 15 years

Other Outcomes (3)

  • Remission rates improvement in Juvenile arthritis (JIA) patients

    Through the entire study, during approximately 15 years

  • Reduction in damage rate in Systemic Lupus Erythematosus patients

    Through the entire study, during approximately 15 years

  • Inclusion of at least 80% of the incident cases of diffuse Systemic sclerosis

    Through the entire study, during approximately 15 years

Study Arms (5)

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

Eligibility Criteria

Age2 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with juvenile idiopathic arthritis, rheumatoid arthritis and seronegative / psoriatic / undifferentiated arthritis, systemic lupus erythematosus or diffuse systemic sclerosis

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

Brussels, 1200, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

residual blood and urine sampling

MeSH Terms

Conditions

Arthritis, JuvenileArthritis, RheumatoidArthritis, PsoriaticLupus Erythematosus, SystemicScleroderma, Diffuse

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesScleroderma, Systemic

Study Officials

  • Patrick Durez, Pr

    UCLouvain - IREC

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

June 3, 2025

Study Start

September 11, 2013

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations