NL-OMON48335尚未招募4 期
INDIGO: 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* - INDIGO
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •Rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis by
- •fulfilling one of the following:
- •o Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or
- •clinical diagnosis of the treating rheumatologist;
- •o Psoriatic arthritis: Classification Criteria for Psoriatic Arthritis (CASPAR)
- •and/or diagnosed with peripheral SpA of the psoriatic arthritis subtype by a
- •rheumatologist;
- •o Axial spondyloarthritis: Assessment of SpondyloArthritis international
- •Society (ASAS) classification criteria and/or clinical diagnosis of the
- •treating rheuma-tologist;
- •Patients using golimumab in the standard dose of 50mg every month for at
- •least three months with a good clinical response, defined as DAS28-CRP <= 2.6
- •for RA, or PASDAS <= 3.2 (PsA) or ASDAS <= 2.1;
- •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.
排除标准
- 未提供
研究者
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