Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)
研究概览
简要总结
The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period
详细描述
This noninferiority study was a multicenter, open-label, randomized trial of patients with rheumatoid arthritis (RA). Patients who did not have an adequate response to methotrexate (MTX) had etanercept (50 mg/week subcutaneously [SC]) added to existing MTX therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses of MTX) at baseline and were followed for 6 months. After 6 months of therapy, participants were randomized in a 1:1 ratio to one of the 2 treatment arms: either discontinue MTX (tapered over 6 weeks) and continue etanercept alone or continue both etanercept plus MTX for an additional 18 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older at the baseline visit
- •An American College of Rheumatology(ACR) diagnosis of rheumatoid arthritis with onset of symptoms of at least 6 months
- •Active disease of at least 3 swollen joints from the Disease Activity Severity 28 at the baseline visit
- •A Disease Activity Severity 28 score of ≥ 3.2 at the baseline visit
- •Have not previously received etanercept therapy
- •Able to start etanercept therapy per the approved product monograph
- •Able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk (or 10 mg/wk in the case of documented intolerance to higher doses) for at least 12 weeks and this dose has been stable at least 4 weeks before the baseline visit
- •The patient or legally acceptable representative must provide written informed consent for participation in the study before any study specific procedures are performed
排除标准
- •Patients who have a positive purified protein derivative (PPD) skin test and who do not have a documented course of anti-tuberculosis therapy. Patients with a positive PPD skin test (equal to or greater than 5 mm), a negative chest x-ray at screening which should be repeated if indicated during of the study, at low risk based on exposure and travel and have initiated a course of anti-tuberculosis therapy of which at least 8 weeks have been completed would be eligible for the study. The full course of anti-tuberculosis therapy must be completed
- •Patients who have previously received infliximab or adalimumab
- •Active infections within 2 weeks of the baseline visit or during the study period
- •Any history of human immunodeficiency (HIV) infection, untreated tuberculosis, multiple sclerosis, congestive heart failure, hepatitis B, hepatitis C, cytopenia, prior or current use of cyclophosphamide or malignancy (other than basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix) in the past 5 years
- •Women who are pregnant or lactating or of childbearing potential who are not using adequate contraception
- •Receipt of any investigational therapy within 4 weeks of the initiation of study medication or during the study period
- •Presence of any significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of etanercept, as outlined in the product monograph
- •Participants not available for follow-up assessment or unable to comply with study procedures
研究组 & 干预措施
Etanercept + Methotrexate
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
干预措施: Etanercept (Biological)
Etanercept + Methotrexate
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
干预措施: Methotrexate (Drug)
Etanercept Only
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
干预措施: Etanercept (Biological)
Etanercept Only
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)
时间窗: Month 6 (randomization) and Month 12
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.
次要结局
- Drug Persistence(Month 6, 12, 18 and 24)
- Disease Activity Score (DAS) 28 Response(Month 6, 12, 18 and 24)
- Change From Baseline in Disease Activity Score 28 (DAS28)(Baseline and Month 6, 12, 18 and 24)
- Change From Baseline in Modified Total Sharp Score (mTSS)(Baseline, Month 12 and Month 24)
- Change From Baseline in Joint Erosion Score(Baseline, Month 12 and Month 24)
- Change From Baseline in Joint Space Narrowing(Baseline, Month 12 and Month 24)
- Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)(Month 6, 12, 18 and 24)
- Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)(Month 6, 12, 18 and 24)
- Change From Month 6 in Short Form 36 Health Survey (SF-36)(Month 6, 12, 18 and 24)
- Change From Month 6 in Work Productivity and Activity Impairment (WPAI)(Month 6, 12, 18 and 24)
- Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)(Month 6, 12, 18 and 24)
- Number of Participants With Adverse Events (AEs)(25 months)