"Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients".
"Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients".
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DOI：
10.1186/1471-2474-15-113
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发表时间：
2014-04-01
影响因子：
2.3
通讯作者：
Curtis JR
中科院分区：
文献类型：
--
作者：
Pappas DA;Kremer JM;Reed G;Greenberg JD;Curtis JR
比较有效性研究最近引起了相当大的关注。研究关节炎和炎症条件的治疗方法的比较有效性登记(SENSE)是一项正在进行的针对成人类风湿性关节炎(RA)患者的前瞻性队列研究。某些利用现有的北美风湿病研究人员联盟(CORRONA)参与的私人和学术网站网络，以招募符合1987年ACR标准的患者，这些患者至少有中度疾病活动。开始或更换生物制剂的患者，无论是抗肿瘤坏死因子治疗还是非抗肿瘤坏死因子生物制剂，都有资格参加登记，这取决于他们的医生选择的治疗方法。招募工作预计将于2014年3月完成，2711名患者将参与这项研究。截至2013年10月7日，已有2234名患者入选。规定每三个月进行一次病人探视和实验室血液检查，为期一年。安全数据收集时间为一年或更长时间。主要的比较有效性终点是在登记前暴露于至少一种先前的肿瘤坏死因子-α抑制剂的患者中，在一年内达到较低的RA疾病活动度。多个次级有效性和安全终点将通过调查所有纳入的人群(幼稚和生物经验)来解决。某些药物独特的设计特点将为选择生物制剂治疗类风湿关节炎提供比较有效和安全的问题。
Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA). CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced). The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.
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DOI：
10.1002/art.20905
发表时间：
2005-02-15
期刊：
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH
影响因子：
--
作者：
Greenberg, JD;Bingham, CI;Kremer, J
通讯作者：
Kremer, J
影响因子：
--
作者：
Sokka, T;Pincus, T
通讯作者：
Pincus, T
影响因子：
27.4
作者：
Kievit, W.;Fransen, J.;van Riel, P. L. C. M.
通讯作者：
van Riel, P. L. C. M.
影响因子：
--
作者：
Zink, Angela;Strangfeld, Anja;Listing, Joachim
通讯作者：
Listing, Joachim
影响因子：
168.9
作者：
Klareskog, L;van der Heijde, D;Sanda, M
通讯作者：
Sanda, M