EUCTR2004-005115-29-DE进行中（未招募）不适用
A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship
GlaxoSmithKline R&D Ltd0 个研究点目标入组 77 人开始时间: 2006年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 77
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. Patient is =18 years of age.
- •2. Patients must use adequate contraception (as defined in protocol) to ensure that no pregnancies occur during the study or for 5 half-lives after the end of the study period.
- •3. Patient has a body mass index (BMI) of =19 kg/m2 but is not morbidly obese.
- •4. Patient has a diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology.
- •5. Patient has serum CRP =15mg/l at screening (maximum 1 week prior to dosing with investigational product).
- •6. Patient has = 3/66 swollen or = 3/68 tender/painful joints at screening.
- •7. Patient has urea and creatinine within normal range at screening.
- •8. The patient must have liver function tests (alanine transaminase, aspartate transaminase and gamma glutamyl transpeptidase) within 1.5 times upper limit of normal (ULN); alkaline phosphatase within 2 times ULN and total bilirubin within normal range at screening.
- •9. Patient must be on stable oral weekly methotrexate (2.5mg – 25mg) for at least 8 weeks prior to screening.
- •10. Any additional oral anti-rheumatic therapies (which may include sulphasalazine [= 2g/day] or hydroxychloroquine) must be stable for at least 8 weeks prior to screening.
- •11. Any additional oral symptomatic relief therapy (which may include NSAIDs or COX-2 inhibitors) must be stable for at least 2 weeks prior to screening.
- •12. The patient must be capable of giving informed consent and can comply with the study requirements and timetable.
- •13. Subjects must have a QTc(b) of less than 430msecs for males and 450msecs for females at screening
- •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. Female subjects who are pregnant or intend to become pregnant during the study period.
- •2. The patient has a 3-month prior history of alcohol use > 21 units per week for males and > 14 units per week for females or the patient has a positive alcohol screen at the screening visit (1 unit of alcohol = ½ pint [284mL] of beer, 125ml of wine or 25ml of spirits).
- •3. The patient has any history of liver disease within 6 months of screening.
- •4. The patient is infected with Hepatitis B or Hepatitis C within 6 months of screening.
- •5. The patient has an active infection.
- •6. The patient has a history of elevated liver function tests on more than one occasion (ALT, AST, ALP or total bilirubin > 1.5 x Upper Limit of Normal [ULN]) in the past 3 months.
- •7. The patient is receiving a biological anti-rheumatic therapy.
- •8. The patient is receiving any dose of oral glucocorticoid.
- •9. The patient has a significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal condition that, in the opinion of the investigator and/or GlaxoSmithKline (GSK) medical monitor, places the patient at an unacceptable risk as a participant in this trial.
- •10. The patient has participated in a clinical trial within the 3 months prior to the study onset for non-biological therapy; or within 4 months of a biological therapy.
- •11. The patient has haemoglobin (Hb) < 9 and platelet count < 150000/mm3
- •12. Hypersensitivity to prednisolone tablet or ingredients
- •13. The patient has a resting systolic blood pressure persistently > 150mmHg or diastolic blood pressure persistently > 90mmHg at screening.
- •14. The patient has a positive urine drug screen, including ethanol.
研究者
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