NCT03670667已完成不适用
The Risk of Cancer Associated With the Use of Abatacept and Other Biologic Agents Among Rheumatoid Arthritis Patients
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,132 人开始时间: 2017年2月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,132
- 试验地点
- 1
- 主要终点
- Incidence of cancer among RA patients treated with anti-TNF's
研究概览
简要总结
An observational study to determine the risk of cancer associated with the use of abatacept and other biologic agents among rheumatoid arthritis patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •RA patients will be identified using algorithms that require ≥ 1 rheumatologist (physician specialty code: 66) diagnosis codes for RA (at least one of the following ICD9 diagnosis codes: 714.0, 714.2, 714.81) at any time before the first claim for a specific drug (Index date) during the study period and ≥1 physician (affiliated with physician evaluation & management codes, listed in the appendix 2) diagnosis codes within 12 months before the first claim for a specific drug use. The index date is defined as the date of the first claim for a specific drug use, and the baseline period is defined as 12 months prior to specific drug use
- •Naive users of biologics, including abatacept, anti-TNFs (i.e. etanercept, adalimumab, certolizumab, golimumab, infliximab), rituximab, and tocilizumab, will be defined specific to each drug as no claim for that therapy in any time prior to the index date
- •Eligible subjects, including cancer patients in SEER and non-cancer beneficiaries from 5% sample, must have been continuously enrolled in Medicare Parts A, B and D and not C at their index date and during baseline
排除标准
- •Patients diagnosed with any cancer (ignoring non-melanoma skin cancer, which is not captured within SEER) before the use of biologics under study. Cancer cases will be identified based on the records in SEER
- •Patients who were younger than 18 years on the index date
- •Patients with claims for other types of auto-immune diseases (e.g. psoriatic arthritis, systemic lupus erythematosus) during baseline
- •Month or year of diagnosis of malignancy in SEER was unknown
- •Cancer cases who were identified by death certificate or autopsy only in SEER
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of cancer among RA patients treated with anti-TNF's
时间窗: Approximately 8 years
Incidence of cancer among RA patients treated with other biologics
时间窗: Approximately 8 years
Incidence of cancer among RA patients treated with abatacept
时间窗: Approximately 8 years
次要结局
- Incidence of cancer relative to the use of TNFi's in patients taking abatacept(Approximately 8 years)
- Incidence of cancer relative to the use of other biologic disease modifiers in patients taking abatacept(Approximately 8 years)
研究者
研究点 (1)
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