NCT00379600已完成2 期
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Anti-inflammatory and Metabolic Effects of Rosiglitazone XR, 8mg Once Daily, in Subjects With Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Disease Activity Score (DAS) following 6 months of treatment
研究概览
简要总结
To assess whether the anti-inflammatory effects of rosiglitazone result in improvements in Rheumatoid Arthritis symptoms in patients for whom their existing Disease Modifying Anti-Rheumatic Drug (DMARD) treatment does not give adequate relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid Arthritis insufficiently controlled by existing disease-modifying anti-rheumatic drugs
- •Subjects will have at least 6 swollen joints plus 2 of the following: 6 tender joints (of 28 joints); early morning stiffness lasting more than 30 minutes; ESR greater or equal to 28mm/h
- •must be receiving a stable dose of disease-modifying anti-rheumatic therapy for at least 2 months prior to participating in the study.
- •Exclusion criteria:
- •Women who are lactating, pregnant, or planning to become pregnant during the course of the study including 30 days following conclusion of study medication
- •Systolic blood pressure (SBP) >165 mmHg or diastolic blood pressure (DBP) >95 mmHg while receiving optimal antihypertensive therapy
- •Any clinically significant abnormality identified on the screening physical exam, laboratory tests, or ECG, which in the judgement of the Investigator makes the subject unsuitable for inclusion in the study
- •a history of alcohol abuse within the past 3 years or consumes >3 units per day for males and >2 units per day for females or has a history of cirrhosis or stigmata of chronic liver disease
- •a history of liver disease or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5 times upper limit of normal and total bilirubin levels greater than 1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin or Gilbert's syndrome) at screening
- •using glucocorticoid at doses >10 mg/day currently or within the last 3 months or may be expected to do so during the course of the study
- •The subject's dose of NSAIDs, COX-2 inhibitors or glucocorticoids has changed at any time during the past 2 weeks prior to screening or may be expected to change during the course of the study
- •The subject's dose or treatment with a statin has changed at any time during the past 3 months prior to screening or may be expected to change during the course of the study
- •a history of renal disease or has serum creatinine = 132mol/L for males and =130mol for females
- •has diabetes mellitus that requires medication or hyperglycaemia with a HbA1c of >7%
- •History of new cardiovascular event within the last 6 months (i.e., intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g., cardiac surgery or angiography plus stenting) scheduled
- •Concurrent or past medical history of congestive heart failure or pulmonary oedema
- •A presence of severe peripheral oedema or a medically serious fluid-related event
- •has significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or immunological 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
- •a history of malignancy in the last 5 years, except for surgically cured basal cell carcinoma (>2 years prior to first dosing)
- •a history of HIV, or chronic hepatitis B or positive C serology
- •a history of drug abuse
- •has participated in a clinical trial within the 3 months before the start of the study for non-biological therapy; or within 6 months of a biological therapy
- •on a biological therapy or has received biological therapy within 6 months prior to screening
- •has donated blood in excess of 500 mL within 56 days prior to dosing
- •The subject is at risk of non-compliance in following directions or adhering to study restrictions
- •a history of drug or other allergy, which, in the opinion of the physician responsible, contraindicates their participation
- •has anaemia defined by haemoglobin concentration <11 g/dL for males or <10 g/dL for females
排除标准
- 未提供
结局指标
主要结局
Disease Activity Score (DAS) following 6 months of treatment
时间窗: 6 Months
次要结局
- Disease activity at 3 months and 6 months, e.g., number of affected joints Patient Assessments of Improvements in Disease Activity, e.g., fatigue and pain assessment Assessment of safety, tolerability and biological activity(Disease activity at 3 months and 6 months)
研究者
研究点 (6)
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