NCT00099554已完成4 期
A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 200
- 主要终点
- Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
研究概览
简要总结
The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults with RA (ACR criteria) for greater than or equal to 6 months
- •Infliximab treatment for at least 18 weeks
- •Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)
- •Failing infliximab defined by ALL of the following at screening and baseline visit: Disease Activity Score (DAS 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints
- •Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening
- •Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening
- •Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks prior to screening
- •Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to 1 week prior to screening
排除标准
- •ACR functional class IV - Prior treatment with etanercept
- •Receipt of any investigational drug/biologic within 28 days of study drug initiation
- •Active infection or predisposition to infection
- •Elective surgery planned during study period
- •Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening
- •Contraindications to etanercept as defined in the package insert
- •Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating events suggestive of multiple sclerosis (MS); Known HIV-positive status; Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure) or positive PPD without adequate TB prophylaxis
结局指标
主要结局
Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
次要结局
- Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16.
- Proportion of subjects who achieve good or moderate DAS28 response at Week 8 and the proportion who achieve remission (DAS28 less than 2.6) at Weeks 8 and 16
- Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16.
- Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16
- Subject incidence rate of SAEs over 16 weeks
研究者
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