A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis

CB Celltech, UK Registered Branch of UCB Pharma SA0 个研究点目标入组 180 人开始时间: 2015年1月22日最近更新: 2017年5月22日

研究概览

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•Subject is informed and given approved written Informed Consent Form (ICF).
•Subject is considered reliable and capable of adhering to the protocol.
•Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months’ duration as defined by ACR/EULAR 2010 classification criteria.
•Subject must have:
•- =6 tender joints (out of 68)
•- =6 swollen joints (out of 66)
•- CRP=10.0mg/L .
•Subject must have had inadequate response to at least 1 synthetic DMARD.
•Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening).
•Female subjects must either be:
•- postmenopausal
•- permanently sterilized or,
•- if of childbearing potential, must be willing to use at least 2 effective methods of contraception,
•Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug.
•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 170
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP).
•Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens.
•Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded.
•Subject is at high risk of infection.
•Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0.
•Subject has renal or liver impairment.
•Subject has a current or past history of gastrointestinal ulceration.
•Subject has active neoplastic disease or history of neoplastic disease.
•Subject has a concomitant diagnosis of any other inflammatory condition.
•Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.

发起方

CB Celltech, UK Registered Branch of UCB Pharma SA