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

Sint Maartenskliniek0 个研究点目标入组 35 人开始时间: 2019年12月12日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•Rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis by fulfilling one of the following:
•oRheumatoid arthritis: either 2010 ACR RA13 and/or 1987 RA14 criteria and/or clinical diagnosis of the treating rheumatologist;
•oPsoriatic arthritis: Classification Criteria for Psoriatic Arthritis (CASPAR)15 and/or diagnosed with peripheral SpA of the psoriatic arthritis subtype by a rheumatologist;
•oAxial spondyloarthritis: Assessment of SpondyloArthritis international Society (ASAS) classification criteria16 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.
•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 35
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

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