SCLERITA - Safety and efficacy of itacitinib in adults with systemic sclerosis: a phase II, randomized, controlled trial - APHP180613

Assistance Publique Hopitaux De Paris0 个研究点目标入组 74 人开始时间: 2024年6月5日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Adult patient (>/= 18 years old), -Patient with a diagnosis of SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria, -Patient with a diagnosis of diffuse SSc, according to LeRoy and Medgser classification -Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score, -Patient with a modified Rodnan skin score (mRSS) > /= 10 and < /= 35 units at screening, -Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months’ duration of the study, -Patient able to give written informed consent prior to participation in the study, -Affiliation to a social security scheme (profit or being entitled). -If patients receive mycophenolate or methotrexate for SSc, these need to be on stable dose as follows: Mycophenolate mofetil/sodium: stable dose for at least 2 months prior to randomisation Methotrexate: stable dose and route of administration for at least 2 months prior to randomisation

•-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 -Patientparticipatinginanotherinvestigational 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

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