Model Early Immunologic Stages of Pediatric Hematological Pre-lupus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorUniversity Hospital, Bordeaux
About this trial
Immunologic thrombocytopenic purpura (ITP) in children is a pre-lupus condition if associated with the presence of anti-nuclear antibodies (ANA), providing a unique model for understanding the natural history of autoimmunity, particularly that of systemic lupus erythematosus (SLE). We will describe the shared and/or unique immunological pathways involved at diagnosis in 70 children with ITP and in 20 children with SLE, and compare them between ITP-ANA- (more often transient), ITP-ANA+ (pre-lupus condition, more often persistent) and SLE
Eligibility criteria
Qualifiers
Child or adolescent with newly diagnosed ITP or SLE according to the specific definitions of ITP or SLE, prior to any treatment,
Over 1 and under 18 years of age at diagnosis, weighing more than 7 kg.
Written consent from parents or guardians,
Patient affiliated to a social security scheme.
Disqualifiers
ITP secondary to a known cause: previous or concomitant immune deficiency, bone marrow or organ transplantation, other autoimmune disease, Evans syndrome (autoimmune hemolytic anemia or autoimmune neutropenia present at ITP diagnosis) or cancer with immunosuppressive therapy.
Treatment with immunomodulation or immunosuppressants (including immunoglobulins, corticoids, hydroxychloroquine), started prior to inclusion (day of sampling).
Pregnant women, women in labour and breastfeeding women
Suffering from an immunological disease,
Trial design
Treatments tested in this trial
- Blood sampling baseline and M3
- Monitoring for SLE
- Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months
- moniktoring for SLE : baseline and M3 then each 6 months until 48 months
Treatment groups
105 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov