NL-OMON48994已完成2 期
PRACTICAL study: Pharmaco-enhancement in Rheumatoid Arthritis with Cobicistat to dose Tofacitinib In Clinic Adequately Low. A within-subject sequential study. - PRACTICA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 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) or Psoriatic arthritis (either
- •Classification Criteria for Psoriatic Arthritis (CASPAR) and/or diagnosed with
- •peripheral SpA of the psoriatic arthritis subtype by a rheumatologist)
- •* Patients using tofacitinib for * 2 weeks in the standard dose of 5mg BID.
- •* Patient informed consent, *18 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
排除标准
- •* 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
研究者
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