EUCTR2009-012055-19-IE进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •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. Diagnosis of RA according to the revised 1987 criteria of the ACR
- •6. DAS28 disease activity score of greater than 3.2 at screening and prior to dosing
- •7. CRP level >0.5 mg/dL at screening and prior to dosing
- •8. Inflamed knee or ankle, as shown by clinical examination or ultrasound
- •9. Has never received a biological (marketed compounds or experimental treatments) or has been treated with a biological and failed due to lack of efficacy (adequate wash-out is required based on the half-life of the previously administered biological; wash-out time should be discussed with GSK Medical Monitor)
- •10. Must have received at least three months of methotrexate (MTX) prior to screening and must be on a stable dose of MTX (up to 25 mg/week) for at least four weeks prior to randomization and be willing to remain on this dose throughout the study
- •11. Must be on a stable dose of folate supplements (a minimum of 5 mg/week) for at least four weeks prior to randomization and throughout the course of the study
- •12. If sulfasalazine is being taken in addition to MTX, the subject must be on a stable dose for at least four weeks prior to screening and be willing to remain on this dose throughout the study
- •13. If hydoxychloroquine or chloroquinine is being taken in addition to MTX, the subject must be on a stable dose for at least three months prior to screening and be willing to remain on this dose throughout the study
- •14. If other oral anti-rheumatic therapies are being taken [e.g., non steroidal anti inflammatory drugs (NSAIDs), cyclo-oxygenase type -2 (COX-2) inhibitors, oral glucocorticoids (e.g. prednisolone 15. Subjects receiving intramuscular glucocorticoids (e.g., methylprednisolone 16. Must have liver function tests including ALT and AST within 1.5 times the ULN and ALP within 3 times ULN at screening. The subject must also have total bilirubin within the ULN at screening.
- •17. QTc<450 msec or QTc<480 msec for subjects with Bundle Branch Block based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
- •11. Has taken cyclosporine, leflonomide, cyclophosphamide or azathioprine within one month of screening. Subjects who have taken cyclosporine, leflonomide, cyclophophamide or azathioprine in the past must have recovered from all drug related AEs.
- •12. Has taken gold salts or d-penicillamine within one month prior to screening. Subjects that have taken gold salts or d-penicillamine in the past must have recovered from all drug related AEs.
- •13. Has received intra-articular or intra-muscular glucocorticoids within one month of screening
- •14. Has received cell-depleting therapy (e.g., rituximab)
- •15. Has received a live vaccine within three months of dosing
- •16. Recent history (within six months of screening) of bleeding disorders, anaemia, peptic ulcer disease, haematemesis or GI bleeding
- •17. Serum iron AND ferritin below the lower limit of the reference range at screening and prior to dosing
- •18. History of B12 or folate deficiency
- •19. A history of haematological disease or acquired platelet disorders, including drug-induced thrombocytopaenia, acute idiopathic thrombocytopaenia or von Willebrand’s disease
- •20. A known risk of intra-cranial hemorrhage including central nervous system surgery within 12 months prior to screening, arterial vascular malformations, aneurysms, significant closed head trauma within 6 months prior to screening or any other incident the investigator and/or medical monitor considers to be relevant
- •21. Hb <10 g/dL and platelet count < 150 x 10 power9 /L
- •22. Donation of blood in excess of 500 mL within a 56 day period prior to dosing
- •23. An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the male subject to use a condom with spermicide in addition to having their female partner use another form of contraception [such as an intra-uterine device (IUD), diaphragm, oral contr
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