NL-OMON21487招募中不适用
INDIGO: INcreasing Dose and Interval of GOlimumab : Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) rheumatoid arthritis (according to 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis confirmed by a rheumatologist)
- •or psoriatic arthritis (according to CASPAR criteria and/or clinical diagnosis of peripheral SpA of the psoriatic arthritis subtype confirmed by a rheumatologist)
- •or axial spondyloarthritis (according to ASAS criteria and/or clinical diagnosis confirmed by a rheumatologist)
- •2) patients using golimumab in the standard dose of 50 mg every month for at least three months with a good clinical response, defined as DAS28-CRP =< 2.6 or PASDAS =< 3.2 or ASDAS =< 2.1
- •3) Informed consent, >= 16 years old and mentally competent
- •4) Ability to measure the outcome of the study in this patient (e.g. patient availability, willing and being able to undergo repeated serum samples)
- •5) Ability to read and communicate well in Dutch
排除标准
- •1) Pregnancy
研究者
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