Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels - GO-LEVE

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 112 人开始时间: 2017年7月19日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Inclusion criteria for cohort 1:
•Aged 18 years or over
•Written informed consent to participate
•Moderate-to-severe UC, defined as:
•-SCCAI > 5 and,
•i.A raised fecal calprotectin (> 59 µg/g) or,
•ii.A raised CRP (> 5 mg/L) or,
•iii.Endoscopic disease activity Mayo 2 or above,
•Evaluated within 4 weeks of screening
•Commencing golimumab treatment
•Sufficient English language skills to understand the patient information sheet and consent form
•Inclusion criteria for cohort 2:
•Aged 18 years or over
•Written informed consent to participate
•Receiving golimumab treatment for UC over 14 weeks (have completed 6 injections at time of screening)
•Sufficient English language skills to understand the patient information sheet and consent form
•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 112
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 112

•Contra-indication to golimumab: tuberculosis, severe infections or congestive cardiac failure
•Imminent need for colectomy (i.e. colectomy is being planned)
•Previous primary non-response to anti-TNF therapy in the opinion of the investigator
•Previous treatment with more than one anti-TNF therapy (excluding golimumab)
•There are no relevant exclusion criteria for patients entering cohort 2.

发起方