NCT00448383已完成3 期
An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-α Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 6,610
- 主要终点
- Change of disease activity score (DAS28) compared with study entry
研究概览
简要总结
This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy.
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
- •Subjects must be 18 years or older
- •ACR criteria for diagnosis of RA for at least 3 months.
- •Active RA as defined by DAS28 >= 3.2 at study entry.
- •Unsatisfactory response or intolerance to prior DMARDs.
- •A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.
- •Use of reliable method of contraception e.g. IUDs, condoms, or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential. Male patients with procreative capacity should also ensure that effective contraception is used during the study and for 70 days after study completion
排除标准
- •Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil.
- •Prior treatment with intravenous immunoglobulin or any investigational agent within 30 days, or 5 half lives of the product, whichever is longer.
- •Prior treatment with investigational biologic therapy (e.g. anti CD4)
- •Treatment within the last 2 months with approved biologic therapy (eg etanercept, infliximab, anakinra)
- •Prior treatment with total lymphoid irradiation
- •History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma.
- •History of or current acute inflammatory joint disease of origin other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
- •History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- •Positive serology for hepatitis B or C indicating active infection
- •History of positive HIV status.
- •Persistent infection, or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
- •Female subjects who are pregnant or breast-feeding.
- •History of clinically significant drug or alcohol abuse in the last year.
- •Previous diagnosis or signs of demyelinating diseases
- •History of active tuberculosis (TB), histoplasmosis or listeriosis.
- •Signs of previous TB infection (chest X-ray signs or positive PPD skin test). The diagnosis of previous TB infection will be based on chest X-ray signs and on PPD skin test.
结局指标
主要结局
Change of disease activity score (DAS28) compared with study entry
时间窗: Week 12
EULAR and ACR response criteria at week 12
时间窗: Week 12
次要结局
- Clinical laboratory parameters(Screening, Week 6 & Week 12 and/or ET)
- Adverse events(Baseline - Week 12)
研究者
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