Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors

Bristol-Myers Squibb International Corporation0 个研究点目标入组 610 人开始时间: 2016年1月18日最近更新: 2018年6月11日

试验速览

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•- Male and female age 18 and above
•- Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
•- Have an inadequate response to methotrexate
•- In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibiotrs
•- Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
•- Have hsCRP of = 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR = 28 mm/hr
•- Willing to use effective birth control for the entire length of the study
•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 488
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 122

•- Diagnosed with juvenile Rheumatoid Arthritis
•- Have been treated with other biologic treatment than a TNF inhibitor
•- Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
•- Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
•- Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
•- Have other autoimmune disease other than RA like lupus, multiple sclerosis
•- Have significant concurrent medical condition at the time of screening or baseline visit

发起方