Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GO

Istituto Clinico Humanitas0 个研究点目标入组 100 人开始时间: 2015年1月19日最近更新: 2019年1月7日

适应症

试验速览

暂无简介。

•a. Patients aged between 18 and 65 at the moment of the inclusion
•b. Ability to understand the procedures of the study and sign the informed consent form
•c. Confirmed diagnosis of ulcerative colitis for at least 6 months.
•d. Naïve to therapy with monoclonal antibodies (both conventional and experimental)
•e. Mayo Score global = 6 at baseline
•f. Steroid-dependence
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a) Diagnosis of Crohn's disease or indeterminate colitis (IBD-U).
•b) Active infection at baseline or a previous infection that has not healed at baseline.
•c) History of solid tumors or blood cancers within 5 years of the inclusion.
•d) Suspected latent tuberculosis infection.
•e) Any other condition deemed risky for the patient during the study.
•f) Pregnancy or lactation at baseline, or planned pregnancy screening up to 3 months after the end of the study.
•g) Concomitant medications at baseline that should be continued during the study and are included in the list of treatments not allowed

发起方

Istituto Clinico Humanitas