ESTUDIO MULTICENTRICO, DE 2 PARTES, PARA EVALUAR LA EFICACIA Y SEGURIDAD DEL GEL H.P. ACTHAR® EN SUJETOS CON ARTRITIS REUMATOIDE CON ENFERMEDAD PERSISTENTEMENTE ACTIVA

Mallinckrodt ARD Inc,0 个研究点目标入组 27 人开始时间: 2017年7月4日最近更新: 2023年9月4日

适应症

试验速览

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•Subjects must be ≥ 18 years of age at Screening Visit and can be male or female. Female subjects must be of nonchildbearing potential (history of hysterectomy, bilateral oophorectomy, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit), or if of childbearing potential must be nonpregnant, nonlactating and agree to use effective contraception with a male partner throughout study participation (through the Follow-up Visit).
•Subjects must meet the criteria for RA as defined by the 2010 ACR/EULAR classification at the Screening Visit
•Subjects must have persistently active RA defined as a DAS28-ESR  3.2 despite treatment with required biologic/nonbiologic DMARD(s) and a corticosteroid as defined below at the Screening and Baseline Visits.
•Subjects must have been on a corticosteroid in the 12 weeks prior to the Screening Visit and on a stable dose of 5 mg to10 mg of prednisone (or prednisone equivalent) for 4 weeks prior to the Screening Visit.

•Subject is from a vulnerable population, as defined by the US CFR Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the IRB/IEC.
•Subject has taken any investigational treatment for RA or any biologic investigational agent in the 24 weeks prior to the first dose of study drug or any nonbiologic investigational agent within 6 weeks prior to the first dose of study drug.
•Subject is unwilling to receive, or is intolerant of, SC injections.
•Subject has any history of use of ACTH preparations for treatment of RA (including but not limited to Acthar and Synacthen®). Subject has a history of sensitivity to ACTH preparations (including but not limited to
•Acthar and Synacthen).
•Subject has a history of sensitivity to porcine protein products.
•Subject has any current rheumatic autoimmune disease other than RA.
•Subject has current inflammatory joint disease other than RA.
•Subject has used B-cell mediated therapies (including, but not limited to rituximab) in the 24 weeks prior to the Screening Visit or will use such treatments during the study.
•Subject has used intraarticular corticosteroids in the 14 days prior to the Screening Visit.
•Subject has any known contraindication(s) to Acthar

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