A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

CB Biopharma Sprl0 个研究点目标入组 60 人开始时间: 2016年6月17日最近更新: 2016年9月26日

适应症

试验速览

暂无简介。

•- Subject must have a diagnosis of adult-onset moderate to severe RA of =15 years duration as
•defined by ACR/ European League Against Rheumatism 2010 classification criteria
•-Subject must have had a stable dose MTX for =3 months prior to Visit 1. The stable dose of MTX should be a minimum of 15mg/week; however, a minimum of 10mg/week is acceptable if the subject was previously not able to tolerate 15mg/week
•-Subject must be biologically naïve
•-Subject must have the following:
•- =6 tender joints (out of 68)
•- =6 swollen joints (out of 66)
•- CRP=10mg/L
•-Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential
•applicable willing to use 1 highly effective method of contraception
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Subject has a past medical history or family history of primary immunodeficiency
•- infected with Tubercolosis (TB) or high risk of acquiring TB infection
•- female subject who is breastfeeding, pregnant or plans to become pregnant during the study or within 20 weeks following the last IMP dose
•- Subject has renal or liver impairment, defined as: Serum creatinine level of >=1.4mg/dL (124mol/L) for females and >=1.5mg/dL (133mol/L) for males
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2x upper limit of
•normal (ULN)
•Total bilirubin >1.5xULN (an isolated total bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%; (ie, is due to Gilbert's syndrome)
•- Subject has any other acute or chronic condition which, in the Investigator’s judgment, would make the subject unsuitable for inclusion in the study
•- Subject has a concomitant diagnosis of any other inflammatory condition
•- Subject had previous exposure to any biologic treatment (ie, anti-TNF or anti-IL-17 inhibitors)

发起方

CB Biopharma Sprl