Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

Exclusion Criteria18

• Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
• Contra-indications to itacitinib or Janus kinase inhibitor,
• Failure to sign the informed consent or unable to consent
• Patient participating in another investigational therapeutic study,
• Acute or chronic active infections, including HBV, HCV, HIV,
• Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
• Patient suspected not to be observant to the proposed treatments,
• Patient who have white blood cell count ≤ 4,000/mm3,
• Patient who have platelet count ≤ 100,000/mm3,
• Patients who have ALT or AST level greater that 3 times the upper limit of normal,
• Patient who have triglyceride level greater than 5g/L
• Pregnant or breastfeeding woman,
• Protected adults (including individual under guardianship by court order),
• Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),
• Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)
• Patient with Systemic Lupus, or Sjögren's syndrome with systemic manifestations justifying immunosuppressive therapy
• Atherosclerotic cardiovascular disease as defined by a history of myocardial infarction, ischaemic stroke, or peripheral artery thrombosis
• Anti-phospholipid syndrome