A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB INCOMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Pfizer Inc.,0 个研究点目标入组 24 人开始时间: 2015年5月29日最近更新: 2023年9月4日

试验速览

暂无简介。

•1.Evidence of a personally signed and dated informed consent document.2.Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, lifestyle guidelines, and other study procedures.3.Male and female subjects aged 18 years or older at the time of informed consent.4.Male and female subjects of childbearing potential and at risk for pregnancy must agree
•to use a highly effective method of contraception throughout the study .5.Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA for at least a 4 month duration.6.Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.7.Subjects must have received oral, subcutaneous (SC), or intramuscular (IM) methotrexate for at least 12 weeks and been on a stable dosefor at least 4 weeks prior to first dose of study drug.FOR MORE DETAILS PLEASE SEE THE PROTOCOL

•1.Pregnant females and breastfeeding females, male subjects with partners currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 6 months after the last dose of study drug.2.Clinically significant laboratory abnormalities at Screening, including but not limited to inadequate bone marrow, liver, renal and immune system function.3.Evidence or history of seizures, or nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain-Barre syndrome).4.Known or Screen test positive for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.5.Evidence of untreated or inadequately treated latent, or inadequately treated active infection with tuberculosis (TB).6.Chest radiography with evidence of active TB, fungal infections, or other clinically significant abnormalities taken at Screening or within 12 weeks prior to Screening..FOR MORE DETAILS PLEASE SEE THE PROTOCO

发起方