Golimumab Intravenous Infusion Registry (GO-IV)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Janssen Inc.
- 入组人数
- 78
- 主要终点
- Number of Participants With Infusion Reactions
研究概览
简要总结
The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion.
详细描述
This is a prospective, observational, non-interventional (no treatment given during course of the study) multi-center (when more than one hospital or medical school team work on a medical research study), study that will enroll participants with rheumatoid arthritis (RA) in Canada. Only data available from source documentation will be collected. The participation in this study will not impact on the standard of care of the participant or any benefits to which they are otherwise entitled. All aspects of treatment decisions and clinical management of participants will be in accordance with clinical practice and at the discretion of the health care provider. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants must have a confirmed diagnosis of rheumatoid arthritis
- •Participants must have provided a written consent for data collection by signing an informed consent form indicating that he/she understand the purpose and procedures for data collection and are willing to participate in the study
- •Participants are golimumab-naive (never have used golimumab both SC and IV formulations)
- •Participants are prescribed golimumab intravenous by an appropriate physician as per the Canadian Product Monograph
- •Exclusion criteria:
- •Participant who has been treated with golimumab in the past
- •Participant has been diagnosed with psoriatic arthritis or ankylosing spondylitis
- •Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point
- •Participant is currently enrolled in an interventional study
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Infusion Reactions
时间窗: Up to end of study (2 years) or early withdrawal
The count of infusion reactions will be reported.
次要结局
- Number of Participants With use of Pre-infusion Medications(Baseline up to end of study (2 years) or early withdrawal)
- Number of Participants With use of Concomitant Medications at Time of Infusion(Baseline up to end of study (2 years) or early withdrawal)
- Number of Participants With Subsequent Reactions After the First Infusion Reaction(Baseline up to end of study (2 years) or early withdrawal)
- Number of Participants With Infusion Reaction Treatments(Baseline up to end of study (2 years) or early withdrawal)
- Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score(Baseline up to end of study (2 years) or early withdrawal)
- Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score(Baseline up to end of study (2 years) or early withdrawal)
- Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score(Baseline up to end of study (2 years) or early withdrawal)