Pappas Dimitrios A, Kremer Joel M, Reed George, Greenberg Jeffrey D, Curtis Jeffrey R
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL 35294-7201, USA.
BMC Musculoskelet Disord. 2014 Apr 1;15:113. doi: 10.1186/1471-2474-15-113.
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).
METHODS/DESIGN: 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.
比较效果研究最近引起了相当大的关注。关节炎和炎性疾病治疗比较效果登记研究（CERTAIN）是一项正在进行的针对类风湿关节炎（RA）成年患者的前瞻性队列研究。
方法/设计：CERTAIN利用现有的北美风湿病研究人员联盟（CORRONA）网络，该网络由参与的私立和学术机构组成，以招募符合1987年美国风湿病学会（ACR）标准且疾病活动至少为中度的患者。根据医生选择的治疗方法，开始或转换生物制剂（抗TNF治疗或非抗TNF生物制剂）的患者有资格入选。预计入组将于2014年3月完成，2711名患者将参与该研究。截至2013年10月7日，已有2234名患者入组。患者需在一年内每三个月进行一次访视和实验室血液检查。安全数据收集一年及以上。主要比较效果终点是在入组前至少接触过一种TNF-α抑制剂的患者中，一年时达到低RA疾病活动度。通过对所有入组人群（初治和有生物制剂使用经验者）进行调查，将探讨多个次要效果和安全终点。
CERTAIN的独特设计特点将为选择生物制剂治疗RA的比较效果和安全性问题提供信息。
