NCT02832297Unknown不适用
Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
Crescendo Bioscience80 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 318
- 试验地点
- 80
- 主要终点
- Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6
研究概览
简要总结
In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 318 biologic-naïve subjects with RA who are candidates for treatment intensification due to inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.
详细描述
To determine whether a strategy of Vectra DA guided care (Arm A), compared with usual care (Arm B), achieves non-inferior clinical outcomes while reducing the cost of treatment in patients with active RA and an inadequate response to MTX monotherapy.
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
- •Subjects will be eligible to participate in the study if they meet all the following criteria:
- •Willing and able to sign an ICF
- •Age 18 to 80 years at enrollment
- •Meets the 2010 ACR/EULAR criteria and/or 1987 criteria for RA, as determined by a board-certified rheumatologist ≥3 months prior to enrollment
- •Received uninterrupted treatment with weekly MTX begun ≥3 months prior to enrollment, at a stable dose of ≥15 mg per week for at least 4 weeks prior to enrollment. A history of therapy with split dose oral MTX or parenteral MTX is acceptable only if the weekly MTX dose was always ≤20 mg/week during the 3 months prior to enrollment.
- •CDAI >10 as assessed by the Investigator at screening
- •At least 3 swollen joints (SJC ≥3) and 3 tender joints (TJC ≥3) out of 28 joints as assessed by the Investigator at screening
- •Must be eligible for treatment intensification with non-biologic and biologic DMARDs
- •Documented evidence of seropositivity (RF and/or anti-CCP antibodies). Seronegative subjects are allowed if erosive disease attributable to RA is documented on X-rays.
排除标准
- •Subjects will be ineligible to participate in the study if they meet any of the following criteria:
- •Use of a non-biologic DMARD other than MTX within 3 months prior to enrollment
- •MTX administered SQ or as an oral split dose at >20 mg/week any time during the 3 months prior to enrollment
- •Two or more DMARDs used in combination (i.e., concomitantly), including but not limited to: MTX, HCQ, SSZ, LEF, cyclosporine, azathioprine, gold or penicillamine any time prior to enrollment
- •Biologic DMARD or JAKi use any time prior to enrollment
- •Any contraindication to use of MTX, HCQ, LEF or biologic DMARDs
- •Opiate use during the 2 weeks prior to enrollment
- •Oral corticosteroids during the month prior to enrollment at a dosage >10 mg/day prednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (or equivalent)
- •MTX intolerance prior to enrollment that limits its use
- •Inflammatory joint disease (other than RA) or any other systemic autoimmune disorder. (Osteoarthritis is not a basis for exclusion.)
- •Primary or secondary immunodeficiency
- •Active infection (excluding fungal infection of nail beds); or acute or chronic infection requiring hospitalization or treatment with parenteral systemic antibiotics within one month of enrollment or treatment with oral antibiotics within 2 weeks of enrollment
- •IA, intravenous or IM corticosteroids during the month prior to enrollment
- •Initiation or non-stable dosing of NSAIDs within 2 weeks prior to enrollment
- •Vectra DA testing within 3 months prior to enrollment
- •Live vaccine within 90 days of enrollment
- •Active substance abuse or psychiatric illness likely to interfere with protocol conduct
- •History of severe allergic or anaphylactic reaction to any monoclonal antibody therapy
- •Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection
- •History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure
- •Pregnancy or inadequate contraception in women of childbearing potential
- •Breast feeding or lactating
- •Medical, psychiatric, cognitive or other conditions that, in the opinion of the Investigator, may compromise the ability of the subject to understand the study information, to give informed consent, to comply with the trial protocol, or to complete the study
- •Presently enrolled in another clinical trial
- •Vectra DA score at screening that is outside the applicable range as required for subject enrollment
- •Note: Screening for TB is not required for subjects participating in the study. If an Investigator is considering a subject for treatment with a biologic DMARD in the study, guidelines for TB screening need to be followed.
研究组 & 干预措施
Vectra DA (Arm A)
Other
Treatment intensification with non-biologic DMARDS guided by Vectra DA
干预措施: Vectra DA (Other)
Usual care (Arm B)
Other
Treatment intensification by usual care without using Vectra DA
干预措施: Usual Care (Other)
结局指标
主要结局
Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6
时间窗: Baseline to 6 months
Change in DAS28 at Month 6
时间窗: Baseline to 6 months
次要结局
- Percentage of subjects with ACR20 response at Month 6(Baseline to 6 months)
- Total cost of RA-related treatment, in US dollars, at Month 6(Baseline to 6 months)
- Change in HAQ-DI score at Month 6(Baseline to 6 months)
- Total cost of RA-related treatment, in US dollars, at Month 12(Baseline to 12 months)
- Percentage of subjects with radiographic non-progression at 12 months(Baseline to 12 months)
研究者
研究点 (80)
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