Treating to Target (T2T) for Patients With Rheumatoid Arthritis in a US Population: Outcomes and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 538
- 试验地点
- 2
- 主要终点
- Disease Activity, probability of treatment acceleration conditional on disease activity.
研究概览
简要总结
The Treat to Target Trial is a clinical trial available to new and existing CORRONA (Data Collection Program) sites. Subjects are recruited to participate in this 12 month trial examining outcomes and feasibility of implementing a Treat to Target approach, when compared with a control group of subjects treated with usual care.
详细描述
New and existing CORRONA sites and patient participants are recruited to participate as subjects in this 12 month trial examining outcomes and feasibility of implementing a Treat to Target approach to RA disease management, requiring routine monthly monitoring and regular escalations of treatment for subjects not achieving low disease activity (LDA) when compared with a control group of subjects treated with usual care.
Purpose The primary purpose of the study is to determine whether practices implementing a multi-dimensional T2T process can more effectively control active Rheumatoid Arthritis (RA) in patients eligible-for-acceleration compared to those practices which continue usual care. The trial will also determine if the process of treating to target for the selected subjects is different between the two groups.
A wide variety of therapies are used in clinical practice to treat patients with RA. The CORRONA Data Collection Program is designed to collect and document utilization patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs), biologic agents, and many other treatments currently used in the management of rheumatic diseases. It is anticipated that the study data may help improve the quality of information upon which clinical decisions are based.
Objectives Co-primary Objectives 1. To measure rates of low disease activity (by CDAI score) between treatment arms (T2T vs usual care) at 12 months.
1a. To assess implementation of a T2T Protocol by comparing rates of acceleration, frequency of visits, time to next visit, and probability of acceleration conditional on disease activity between subjects treated in a T2T intervention group, compared with a control group treated with usual care (UC) at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patients eligible for the study will be both male and female adult (at least 18 years of age) patients who have a documented diagnosis of RA, are enrolled or willing to be enrolled in the CORRONA registry for the duration of the trial, have signed appropriate informed consent documents, are willing to participate in the trial, are medically appropriate for participation in the opinion of the investigator, and have moderate to severe RA disease activity as defined by CDAI >10.
排除标准
- •Patients under the age of 18
- •Women who are pregnant, breastfeeding or planning to become pregnant during the study period.
- •Patients with chronic or acute pain condition(s) other than active RA which, in the opinion of the investigator, is likely to confound or interfere with assessments of RA disease activity.
- •Functional class IV as defined by the ACR classification of functional status
- •Patients receiving a daily dose of prednisone of >10 mg within the 4 weeks prior to enrollment.
- •History of positive tuberculin skin test or equivalents that have not received documented treatment for latent tuberculosis (TB).
- •Patients with a significant, uncontrolled concomitant illness such as, but not limited to cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepatic, metabolic, pulmonary or lymphatic disease.
结局指标
主要结局
Disease Activity, probability of treatment acceleration conditional on disease activity.
时间窗: 1 year
CDAI Score, rates of acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity.
次要结局
- Disease activity scores, reasons for ineligibility for treatment acceleration, frequency of toxicity, frequency of TAEs.(1 year)