EUCTR2009-012055-19-FR
进行中（未招募）
1 期
A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Rheumatoid arthritis
- 发起方
- GlaxoSmithKline Research & Development Limited
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Males or females between 18 and 75 years of age, inclusive
- •2\. Using acceptable contraception to ensure that no pregnancies occur during the course of the study and for at least 12 weeks after receiving the last dose for male subjects and for 32 weeks after receiving the last dose for female subjects (see Section 8\.1 of the protocol on contraception for more details)
- •3\. Body mass index within the range 18\.5 \- 35 kg/m2 inclusive
- •4\. Capable of giving informed consent and can comply with the study requirements and timetable
- •5\. In France, a subject will be eligible for inclusion in this study if he or she is affiliated
- •with or a beneficiary of a social security category
- •6\. Diagnosis of RA according to the revised 1987 criteria of the ACR
- •7\. DAS28 disease activity score of greater than 3\.2 at screening and prior to dosing
- •8\. CRP level \>0\.5 mg/dL at screening and prior to dosing
- •9\. Inflamed knee or ankle (or whichever inflamed joint will be biopsied), as shown by clinical examination or ultrasound
排除标准
- •1\. Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12\-lead or Holter); at the discretion of the investigator
- •2\. Positive Hepatitis B surface antigen or Hepatitis C antibody at screening
- •3\. History of human immunodeficiency virus or other immunodeficiency disease at screening
- •4\. A history of elevated liver function tests on more than one occasion (ALT, AST and ALP \> 3 times the ULN; total bilirubin \> 1\.5 times the ULN) in the 6 months prior to screening
- •5\. Previous exposure or past infection caused by mycobacterium tuberculosis, unless adequately treated (documentation of treatment must be provided to the investigator and reviewed by the investigator and GSK Medical Monitor)
- •6\. An acute infection
- •7\. A history of repeated, chronic or opportunistic infections that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial
- •8\. A history of malignancy, except for adequately treated, non\-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix (an exception would be adequately treated cancer \>10 years prior to screening; documentation of treatment must be provided to the investigator and reviewed by the investigator and GSK Medical Monitor)
- •9\. Calculated creatinine clearance\< 50mL/min
- •10\. Significant cardiac, pulmonary, metabolic, renal, hepatic or GI conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial
结局指标
主要结局
未指定
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