Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,279
- 主要终点
- Proportion of Patients With an Infusion Reaction Through Week 52
研究概览
简要总结
The purpose of this study is to compare the proportion of patients with an infusion reaction in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.
详细描述
This is a prospective, noninterventional (no treatment medication provided by the study), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multicenter (study conducted at multiple sites) study of Golimumab IV and Infliximab in RA patients. The study allows for an anticipated 2-year enrollment period and a 3-year study duration for each patient. No interventions will be given to patients as a part of this study. This study will be conducted in the US, at rheumatology-based clinical practices and will enroll adult RA patients who meet all entry criteria. The primary endpoint of this study is the proportion of patients with an infusion reaction through week 52. Patients will be enrolled in a 1:1 ratio to initiate treatment with either Golimumab IV or Infliximab. Patients' 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
- •Patient must be a male or female 18 years of age or older as the study is intended to assess Golimumab intravenous (IV) and Infliximab in adult RA patients
- •Patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- •Patient has a confirmed diagnosis of Rheumatoid arthritis (RA) and is medically eligible for treatment with Golimumab IV or Infliximab in accordance with standard of care (example, screening for tuberculosis [TB], vaccinations, etc.)
- •At the time of enrollment the patient will be initiating treatment with Golimumab IV or Infliximab. The patient may or may not have previously received treatment with a biologic. Patients with previous exposure to subcutaneously administered Simponi may enroll in the study
- •Patient must be willing to complete Patient reported outcomes (PRO) forms during the study and agree to return completed forms to the site if receiving an infusion of Golimumab IV or Infliximab at a location remote from the study site
排除标准
- •Patient is less than 18 years of age
- •Patient is pregnant or planning a pregnancy
- •Patient is currently enrolled in an interventional study
- •Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days, as appropriate, before the planned first dose of Golimumab IV or Infliximab
- •Patient previously received Golimumab IV if planning to receive Golimumab IV in this study or the patient previously received Infliximab if planning to receive Infliximab or BI in this study. Patient previously receive BI if planning to receive BI or Remicade in this study
- •Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the patient's well-being) or that could prevent, limit, or confound the protocol-specified assessments
结局指标
主要结局
Proportion of Patients With an Infusion Reaction Through Week 52
时间窗: Up to week 52
An infusion reaction is any adverse event that occurs during an infusion or within 1 hour of completion of infusion of either Golimumab IV or Infliximab. The number of patients with infusion reactions will be reported.
次要结局
- Change from Baseline in CDAI Score in Bionaïve Patients at Month 12(Baseline and Month 12)
- Number of Infusions With Infusion Reactions(3 years)
- CDAI Score in Patients with or Without Concomitant Methotrexate use(Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36))
- Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use(Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36))
- Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6(Baseline and Month 6)
- Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])(Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36))
- Number of Patients with Adverse Events (AEs) and Serious AEs(3 years)
- Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction(Up to week 52)
- Change from Baseline in CDAI Score in Bionaïve Patients at Month 3(Baseline and Month 3)
- Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction(3 years)
- Number of Patients With an Infusion Reaction(3 years)
- CDAI Score in Dose-escalated Patients(Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36))
- Change from Baseline in CDAI Score in Dose-escalated Patients(Baseline, Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36))
- CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])(Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36))
- Discontinuation Rates(3 years)
- Persistency of use of Treatment(3 years)