Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT04001556
Eligibility Criteria:
Inclusion Criteria:
* Patients over eighteen years old;
* Fulfilling 2013 ACR classification criteria for Systemic sclerosis (Van den Hoogen et al. 2013);
* 60 patients with subjective sicca symptoms reported by a standardised questionnaire (Vitali C et al. 2002);
* 15 patients without sicca symptoms;
* Who has signed an informed consent
* Benefiting from a social security scheme
Exclusion Criteria:
* Treatment: current (or in the past 6 months) immunosuppressive treatment by rituximab or cyclophosphamide (representing less than 5% of SSc patients in the investigator's centres);
* Current (or in the past 6 months) treatment with drugs with anti-cholinergic properties (Selective Serotonin Reuptake Inhibitors and anti-histaminic inhibitors (hydroxyzine));
* Current treatment with antiplatelet aggregates
* Anti-vitamin K treatment (increasing risk of bleeding during minor salivary gland biopsy); and oral anti-coagulant
* Known abnormal coagulation (prolonged aPPT(activated partial thromboplastin time) and / or PT (Prothrombin time ( \<70%)), or known thrombocytopenia (\<150,000 platelets / mm3)
* Known secondary sicca symptoms : history of head-and-neck radiotherapy, hepatitis C infection, AIDS, sarcoidosis, amyloidosis, graft-vs-host disease and IgG4(Isotype's immunoGlobulin G4)-related disease;
* Pregnancy or breastfeeding mothers;
* Known intolerance/allergy to xylocain injection;
* Adults legally protected (under judicial protection, guardianship, or supervision), inability to consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04001556
Study Brief:
Protocol Section:
NCT04001556