CLOPIDOGREL for Systemic sclerosis | Raynaud phenomenon

Inclusion criteria

• {"criterion_text":"- Patient over 18 years old, and less than 85 years old.\n- Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere, anti-RNApolIII, or any other autoantibodies related to systemic sclerosis.\n- Patient with RP reported by the subject and confirmed by the physician.\n- Patient affiliated to a health insurance system.\n- Patient who accepts to participate to the study and signs an inform consent form."}

Exclusion criteria

• {"criterion_text":"- Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.\n- Patient with skin fibrosis at screening.\n- Patient with antiplatelet treatment at screening.\n- Patient with contraindications to clopidogrel.\n- Patient treated by immunosuppressive agent at screening.\n- Patient treated by anticoagulants at screening.\n- Women of childbearing age refusing effective contraception method during the the study treatment (24 months).\n- Incompetent adults (i.e. Individuals under the protection of a conservator)."}

Primary endpoints

• {"endpoint_text":"- Occurrence of SSc at 5 years according to ACR / EULAR 2013 criteria in the two randomization groups","definition_or_measurement_approach":"Occurrence of systemic sclerosis (SSc) at 5 years assessed according to ACR/EULAR 2013 criteria."}

Secondary endpoints

• {"endpoint_text":"- Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups","definition_or_measurement_approach":"Clinical assessment of cutaneous fibrosis (sclerodactyly or other area) by at least two independent investigators; frequency compared between groups."}
• {"endpoint_text":"- Mean of modified Rodman skin score in the two randomization groups","definition_or_measurement_approach":"Mean modified Rodnan skin score compared between randomization groups."}
• {"endpoint_text":"- Mean of Cochin Hand Function Scale in the two randomization groups","definition_or_measurement_approach":"Mean Cochin Hand Function Scale score compared between groups (assessed at 2 and 5 years as indicated)."}
• {"endpoint_text":"- Demographic (sex, age, environmental factors), clinical (associated diseases, history), biological, capillaroscopic criteria in the two randomization groups","definition_or_measurement_approach":"Assessment of demographic, clinical, biologic and capillaroscopic prognostic factors associated with risk of developing SSc, compared between randomization groups."}

France

Earliest CTIS Part Ii Submission Date

18-01-2024

Latest Decision Or Authorization Date

11-07-2025

Processing Time Days

540

Number Of Sites

11

Number Of Participants

90

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"Ministère de la Santé (France)","duties_or_roles":"Source of monetary support","organisation_type":""}