EUCTR2005-000158-61-LT进行中（未招募）不适用
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,210
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.Subject is a male or female outpatient, at least 18 years of age.
- •A female is eligible to enter and participate in the study if she is of:
- •a.Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); or,
- •b.Childbearing potential, has a negative pregnancy test and is not lactating at the Screening Visit and Baseline Visit, and agrees to satisfying one of the requirements listed in the protocol : Acceptable Methods of Contraception.
- •2.Subject is able and willing to give written informed consent.
- •3.Subject is able to read, comprehend and record information required in the protocol, e.g., complete assessments using an electronic device.
- •4.Onset of RA at >16 years of age and symptom duration for >12 months.
- •5.Diagnosis of RA as defined by the American Rheumatism Association (ARA) 1987 criteria.
- •6.ARA Functional Class I, II or III.
- •7.Required a NSAID or COX-2 inhibitor for the treatment of their RA for at least 5 out of 7 days of each week for the 4 weeks prior to screen.
- •8.Satisfies all the following definitions of active disease and baseline criteria defined by:
- •a minimum of six tender/painful joints at baseline with an increase of at least two tender/painful joints (or 20% increase, whichever is greater) at baseline compared to screen, plus
- •a minimum of three swollen joints at baseline with an increase of at least two swollen joints (or 20% increase, whichever is greater) at baseline compared to screen, plus
- •a patient’s assessment of pain (VAS) of at least 40mm at baseline with an increase of at least 10mm (or 20% increase, whichever is greater) at baseline as compared to screen.
- •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
- •Listed below are the principal exclusion criteria with numbers corresponding to those used in the protocol. Please refer to protocol for full list of criteria.
- •5. Active gastrointestinal (GI) ulceration of the upper GI tract within the previous 6 months, bleeding of the upper GI tract within the previous year (including hematemesis).
- •8. Use of proton pump inhibitors (e.g., omeprazole, lansoprazole) at a dose outside those specified in the label.
- •11. History of coronary artery disease (angina [stable or unstable], myocardial infarction or any coronary artery surgery). Not myocardial infarction includes history of clinical event or age-indeterminate event on ECG. Subjects with a screening ECG indicating a previous myocardial infarction, as reported by the central ECG reader, are excluded.
- •12. History of congestive heart failure or renal artery stenosis
- •13. History of stroke or transient ischemic attack
- •14. Uncontrolled hypertension (treated or untreated) at screen (sitting systolic blood pressure [SBP] >160mmHg and/or sitting diastolic blood pressure [DBP] >90mmHg).
- •15. Subjects taking aspirin regularly as an analgesic and are unable to washout 5x’s the half-life prior to base line are excluded; low dose [=325mg per day] for cardiovascular prophylaxis is permitted during the study.
- •16. Use of a combination of a diuretic with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). Note that subjects taking only a diuretic, or only an ACE/ARB drug, are not excluded. Agents covered by this criteria are listed in (Appendix 6).
- •17. Use of anticoagulants (warfarin, heparin) or anti-platelet aggregation agents (excluding low-dose aspirin) or a condition associated with decreased haemostasis.
- •21. Participation in another investigational drug or device study during the 3 months prior to the Baseline/Randomisation Visit, participation in a study of a marketed NSAID or COX-2 inhibitor, given in accordance with the dosage and administration section of the approved product labelling, during the month prior to the Baseline/Randomisation Visit, or will participate simultaneously in another clinical study.
- •23. Initiation or change of dose of a standard disease modifying anti-rheumatic drug (DMARD) within 12 weeks prior to baseline, e.g., penicillamine, sulfasalazine, oral or intramuscular gold salts, azathioprine, antimalarials and leflunomide (Arava).
- •24. Use of methotrexate at doses of >20mg/week or initiation or change to the dose of methotrexate within 8 weeks prior to baseline.
- •25. Use at doses outside those specified in the label of biological anticytokine directed therapeutics (e.g., anti-tumor necrosis factor [TNF]) or given at a dose interval other than the following: at least weekly, every 2 weeks, or every 4 weeks. These agents, at allowed dose intervals, may be used if stable for 6 months prior to baseline.
- •26. Use of B-cell targeted therapy (e.g., rituximab) if not stable for 6 months prior to Screen or at doses/schedules outside the label. Appropriate monitoring must have been performed.
- •27. Use of oral corticosteroids at doses greater than the equivalent of 10 mg/day of prednisolone/prednisone (average daily dose for patients on alternating doses) or initiation of treatment within 4 weeks prior to commencing study drug. Corticosteroid doses should remain stable throughout the study.
- •28. Intra-articular injections within 4 weeks prior to commencing study drug or during the study period (or antic
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