Metagenomic analysis of the gut microbiota in patients with psoriatic arthritis upon treatment with the jak-stat inhibitor tofacitinib: correlations with immunological, clinical and imaging markers - MiCROBPsA

AZIENDA OSPEDALIERA SANT'ANDREA0 个研究点目标入组 20 人开始时间: 2021年6月17日最近更新: 2021年8月30日

适应症

试验速览

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•-Male or female, 18 to 65 years of age, inclusive
•-PsA diagnosis according to the CASPAR criteria, moderate to severe activity (more than 4 swollen joints and/or DAPSA = 15 and/or ASDASpcr = 1.3 and/or BASDAI =4),
•-able to understand the study procedures and sign the informed consent.
•-Current therapy with methotrexate at standard dosage.
•-Inadequate responder, as for EULAR response criteria, to at least six months methotrexate therapy at standard dosage
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Any sort of contraindications to tofacitinib at the time of enrolment as for local label (SmPc), hypersensitivity to the active substance or to any of the excipients, active tuberculosis, serious infections such as sepsis or opportunistic infections, severe hepatic impairment, pregnancy and lactation, malignancies, known risk factors for VTE, any uncontrolled clinically significant laboratory abnormality, experiencing intolerance to MTX

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