Pharmaco-enhancement in Rheumatoid Arthritis with Cobicistat to dose Tofacitinib In Clinic Adequately Low. A within-subject sequential study.

Radboudumc0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年6月11日

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•Rheumatoid arthritis (either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion)
•Patients using tofacitinib for = 2 weeks in the standard dose of 5mg BID. In addition, for patients that have used tofacitinib >3 months, it is required that a good response is achieved defined as a DAS28-CRP < 2.9 or the judgement of the rheumatologist that disease activity is low.
•Patient informed consent, =16 years old and mentally competent
•Ability to measure the outcome of the study in this patient (e.g. patient availability; willing and being able to undergo repeated serum samples)
•Ability to read and communicate well in Dutch

•Concomitant use of inducers or potent inhibitors of CYP3A4 or moderate inhibitors of CYP3A4 and potent inhibitors of CYP2C19, or medication sensitive to changes in metabolism as a result of cobicistat co-treatment, as assessed with the KNMP G-standaard” unless an alternative is listed in Table 1.
•Known contra-indications for treatment with cobicistat in line with the summary of product characteristics.

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