NCT00783536撤回4 期
An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Low disease activity
研究概览
简要总结
This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the previous 6 months will be eligible for the study. Study subjects will be randomized into one of two treatments groups and receive either etanercept + methotrexate or standard non-biologic DMARD therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject age 18 years or older
- •Diagnosis of RA
- •Disease duration of ≥ 6 months and ≤ 2 years
- •Active disease at the time of randomization
- •Negative serum pregnancy test at screening if female of childbearing potential.
- •Women of childbearing potential participating in the study must use a medically acceptable form of contraception.
- •Sexually active male must agree to use a medically accepted form of contraception during the study. If partner is using and acceptable form of contraception, this criteria is not applicable.
- •Subject is capable of understanding and signing an informed consent form
- •Subject is able and willing to self-inject study drug or have a designee who can do so
- •Subject is able and willing to take oral medication
- •Subject is able to store injectable test article at 2° C to 8° C
- •Demonstrates a negative tuberculosis screening test determined by chest
- •Exculsion Criteria:
- •Subject has received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist
- •Subject has received any of the following DMARDs: methotrexate, leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, azathioprine, D-penicillamine, cyclophosphamide within the 6 months of screening visit by the rheumatologist
- •Subject has received any investigational drug within 3 months of screening visit by the rheumatologist
- •Subject has received any biologic agent in the past
- •Subject has received any live (attenuated) vaccines within 4 weeks of screening visit by the rheumatologist
- •Subject has received intra-articular corticosteroid injection within 4 weeks of screening visit by the rheumatologist
- •Subject has received bolus intramuscular/intravenous treatment with corticosteroids (>20 mg prednisone or equivalent) within 4 weeks of screening visit by the rheumatologist
- •Subject is taking > 10 mg/day of prednisone or equivalent within 4 weeks of screening visit by the rheumatologist
- •A history or active presence of any of the following items will prevent enrollment:
- •Significant concurrent medical diseases including cancer or a history of cancer Renal disease (creatinine level > 175 ?mol/L) History of drug abuse or psychiatric disease that would interfere with the subject's ability to comply with the requirements of this protocol.
- •History of alcohol abuse that would interfere with the subject's ability to comply with the requirements of this protocol.
- •History of known liver cirrhosis, fibrosis, or fatty liver History of any viral hepatitis within 1 year of screening
- •Active presence of the following will also prevent enrollment Subject has a significant active infection or any underlying diseases that could predispose subjects to infections according to the investigators criteria Demonstrates liver function abnormality through clinical significant hepatic enzymes results ( twice the upper limits of normal).
- •Subject has leucopoenia (white blood cells < 3500 x 106/L) Subject has thrombocytopenia (platelets < 125 x 109/L) Subject has a hemoglobin level of < 85 g/L Subject is scheduled for elective major surgery within the first year of study participation Pregnant or lactating women. Positive TB by PPD and abnormal chest ray
- •Subject has a history of confirmed blood dyscrasias
- •Subject has any condition judged by the physician to cause this study to be detrimental to the subject.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
- Clinical and demographic information
- Clinical and Laboratory information
干预措施: Etanercept + Methotrexate (Drug)
2
Active Comparator
- Clinical and demographic information
- Clinical and Laboratory information
干预措施: DMARDS (Drug)
结局指标
主要结局
Low disease activity
时间窗: 6 months
次要结局
- Effect of the combination therapy on physical function(6 months)
研究者
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