EUCTR2016-000498-19-BG进行中（未招募）1 期
A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 580
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 18 to 76
- •- Completion of treatment period through Day 84 as specified in Study
- •- Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
- •- Have not received any prohibited medications in Study GA29350
- •- While taking MTX, must be willing to receive oral folic acid (at least 5 milligram [mg]/week)
- •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 430
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •- Met protocol defined treatment stopping criteria during Study GA29350
- •- Treatment with any investigational agent (other than study drug) or live/attenuated vaccine during Study GA29350 or since the last administration of study drug in Study GA29350
- •- In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity, such as neurological, cardiac (e.g., moderate to severe heart failure New York Heart Association [NYHA] Class III/IV), pulmonary, renal, hepatic, endocrine, or GI disorders (excluding RA) that would increase the risk to the patient in Study GA30067
- •- Pregnant or lactating, or intending to become pregnant during the study
- •- Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient’s participation in the study in the opinion of the investigator
- •- Patients who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV during the Phase II Study GA29350
研究者
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