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New treatment option for Scleroderma
Official title Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
ClinicalTrials.gov ID: NCT05098704
What this study is testing
What is clopidogrel treatment?
clopidogrel treatment is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for scleroderma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patient over 18 years old, and less than 85 years old.
- Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere or anti-RNApolIII, or any other auto-antibodies...
- Patient with RP reported by the subject and confirmed by the physician.
- Patient affiliated to a health insurance system.
- Patient who accepts to participate to the study and signs an inform consent form.
You likely can't join if
- Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.
- Patient with skin fibrosis at screening.
- Patient with antiplatelet treatment at screening.
- Patient with contraindications to clopidogrel.
- Patient treated by immunosuppressive agent at screening.
- Patient treated by anticoagulants at screening
See the full eligibility criteria
- Patient over 18 years old, and less than 85 years old.
- Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere or anti-RNApolIII, or any other auto-antibodies related to systemic sclerosis
- Patient with RP reported by the subject and confirmed by the physician.
- Patient affiliated to a health insurance system.
- Patient who accepts to participate to the study and signs an inform consent form.
- Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.
- Patient with skin fibrosis at screening.
- Patient with antiplatelet treatment at screening.
- Patient with contraindications to clopidogrel.
- Patient treated by immunosuppressive agent at screening.
- Patient treated by anticoagulants at screening
- Pregnant or breastfeeding women.
- Women of childbearing age refusing effective contraception method during the study treatment (24 months).
- Incompetent adults (i.e. Individuals under the protection of a conservator)
The study team makes the final eligibility decision.
Where it's taking place
- Bayonne, France
- Bordeaux, France
- Brest, France
- Grenoble, France
- Libourne, France
- Mont-de-Marsan, France
- Paris, France
- Pau, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayonne, France; Bordeaux, France; Brest, France; Grenoble, France; Libourne, France; Mont-de-Marsan, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.