Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to conducting quality research on this disease remains the development of well-documented patient cohorts with reliable biological samples. The main objective of this cohort is to study the natural progression of SSc in a cohort of patients followed over 5 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient over 18 years old
Patient with systemic scleroderma according to the ACR/EULAR 2013 criteria, or with a " very early systemic sclerosis " defined by the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).
Person affiliated or benefiting from a social security scheme.
Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research)
Disqualifiers
Pregnant or breastfeeding woman
Patient under guardianship, curatorship or any other legal protection regime
Trial design
Design model
Single group
Treatments tested in this trial
Blood samples
Biological/Vaccine62 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Biopsy
Other interventionSkin biopsies only for volunteers among patients
Bronchoalveolar samples
Other intervention50 ml of bronchoalveolar samples if pulmonary flare requires this type of exploration only for volunteers among patients
Biopsy
Other interventionDigestives biopsies if requires this type of exploration in the standard of care only for volunteers among patients
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: subjects SSc diagnosedExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change of the main clinical characteristics of scleroderma patients
Worsening of the SSc according to the onset of a renal crisis (according to arterial hypertension \> 150/85 mm Hg ), a pulmonary arterial hypertension (identified with a right heart catheterization), or an interstitial lung disease (identified with a chest CT-scan).
Time frame
At baseline (Day 0) and 60 months after baselineSecondary outcomes
1
Proportion of pulmonary arterial hypertension diagnosis in SSc patients
Time frame
At baseline (Day 0) and 60 months after baseline2
Proportion of interstitial lung disease diagnosis in SSc patients
Time frame
At baseline (Day 0) and 60 months after baseline3
Proportion of renal crisis diagnosis in SSc patients
Time frame
At baseline (Day 0) and 60 months after baseline4
Mean of Rodnan score for the evaluation of disease activity for SSc patients, with higher values mean higher disease activity.
(Min value: 0 - Max value: 51)
Time frame
At baseline (Day 0) and 60 months after baselineSponsors and contacts
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Source ClinicalTrials.gov