EUCTR2005-002969-37-SE进行中（未招募）不适用
A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. The patient is = 18 years of age.
- •2. To be eligible, female patients must have a negative pregnancy test (i.e. serum beta hCG test) and be of:
- •a) non-childbearing potential (i.e. physiologically incapable of becoming pregnant).
- •This includes any female who is post-menopausal. For the purposes of this study,
- •post menopausal is defined as being amenorrhoeic for greater than 2 years with an
- •appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms.
- •Postmenopausal status will be confirmed by serum FSH and oestradiol
- •concentrations at screening. Surgical sterility will be defined as females who have
- •had a hysterectomy and/or bilateral oophorectomy or tubal ligation.
- •b) childbearing potential and agrees to commit to one of the protocol-approved
- •methods of contraception, when used consistently and in accordance with both the
- •product label and the instructions of a physician, as indicated in Section 7.1.
- •3. The patient has a body mass index (BMI) within the range of 18.5-35.0 Kg/m2.
- •4. The patient has a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR).
- •5. The patient has serum CRP = 10mg/l at screening (maximum 1 week prior to dosing with investigational product).
- •6. The patient has = 3/66 swollen or = 3/68 tender/painful joints at screening.
- •7. The patient has urea and creatinine within normal range at screening.
- •8. The patient must have liver function tests (ALT, AST and gamma GT) within 1.5 times the upper limit of normal (ULN); ALP within 2 times the upper limit of normal and total bilirubin within normal range at screening.
- •9. The patient must be on stable weekly methotrexate (2.5mg – 25mg) for at least eight weeks prior to screening (i.e. dose unchanged throughout the 8 week period).
- •10. Any additional oral anti-rheumatic therapies (which may include sulphasalazine [= 3g/day] or hydroxychloroquine or glucocorticoid = 10mg/day) must be stable for at least eight 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
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. The patient has a three month prior history of alcohol use > 21 units per week for males and > 14 units per week for females (1 unit of alcohol = ½ pint [284mL] of beer, 125mL of wine or 25mL of spirits).
- •2. The patient has any history of liver disease within 6 months of screening.
- •3. The patient is infected with Hepatitis B or Hepatitis C.
- •4. The patient has an active infection.
- •5. The patient has a history of elevated liver function tests on more than one occasion (ALT, AST or total bilirubin > 1.5 x ULN) in the past 3 months.
- •6. The patient is receiving a biological anti-rheumatic therapy.
- •7. 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.
- •8. 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.
- •9. The patient has haemoglobin (Hb) < 9 or platelet count < 150000/mm3
- •10. The patient has a resting systolic blood pressure persistently > 150mmHg or diastolic blood pressure persistently > 90mmHg at screening.
- •11. 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/spermicide in addition to having their female partner use another form of contraception, such as: an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if the woman could become pregnant from the time of the first dose of study medication until completion of follow-up procedures.
- •12. Patients who are pregnant or nursing.
研究者
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