Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 主要终点
- Treatment Adherence Measured by Continuous Measures of Medication Gaps (CMG)
研究概览
简要总结
The purpose of this study is to describe adherence to golimumab in Colombian participants with rheumatoid arthritis (RA) experiencing adequate treatment response, in a real-world clinical settings.
详细描述
This is a multi-center (when more than one hospital or medical school team work on a medical research study), non-interventional, prospective cohort study that will enroll participants with RA in Colombia, for whom the treating physician has decided to treat with golimumab prior to enrolment. All participants will be observed for adherence to golimumab treatment for 24 months from study start (Week 0), and recommended follow up assessments will be every 3 months. Any changes including addition of new medications or dose modifications of existing medications will be entirely according to the treating physician's judgment. 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 with moderate to severe RA for whom the physician had decided to treat with golimumab according to the local product label, with the first dose being administered between 12 and 26 weeks prior to study enrollment
- •Participants who have achieved an adequate therapeutic response to regular doses of golimumab, within 12 to 26 weeks of treatment
- •Participants should be evaluated for tuberculosis (TB) exposure/risk factors or managed for active and latent TB (per local requirements and according to the local product label)
- •Participants who have been evaluated for active/latent hepatitis B virus (HBV) and hepatitis C virus (HCV)
- •Participants for whom, since golimumab initiation, a complete medical record is available
- •Exclusion criteria:
- •Participants who have received and terminated golimumab treatment in the past
- •Participants that have been treated with golimumab for more than 26 weeks prior to enrolment in the study
- •Participants with use of any other investigational agent less than or equal to 30 days before starting treatment with golimumab
- •Participants with suspected latent TB, having not received prophylactic treatment of at least 4 weeks
- •Participants with suspected or active TB
- •Participants with active/latent HBV or HCV
排除标准
- 未提供
结局指标
主要结局
Treatment Adherence Measured by Continuous Measures of Medication Gaps (CMG)
时间窗: 24 months
Adherence rates to golimumab will be measured by the Continuous Measures of Medication Gaps (CMG). CMG provides an approximate percentage of time in which a participant is without medication available for use. Number of days of delay between consecutive golimumab injections will be observed throughout the study.
次要结局
- Change From Baseline in Patient's Global Assessment (PtGA) at Month 6, 12, 18, and 24 or Early Termination(Baseline, Month 6, 12, 18, and 24 or Early Termination)
- Change From Baseline in Functional Status at Month 6, 12, 18, and 24 or Early Termination(Baseline, Month 6, 12, 18, and 24 or Early Termination)
- Number of Treatment Termination(24 months)
- Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation(24 months)
- Frequency of Treatment Suspension(24 months)
- Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Month 6, 12, 18, and 24 or Early Termination(Baseline, Month 6, 12, 18, and 24 or Early Termination)
- Change From Baseline in 28-Joint Disease Activity Score (DAS-28) at Month 6, 12, 18, and 24 or Early Termination(Baseline, Month 6, 12, 18, and 24 or Early Termination)
- Change From Baseline in Work Related Productivity at Month 6, 12, 18, and 24 or Early Termination(Baseline, Month 6, 12, 18, and 24 or Early Termination)
- Change From Baseline in Quality of Life at Month 12 and 24 or Early Termination(Baseline, Month 12 and 24 or Early Termination)
- Change from Baseline in Utilization of Health Care Resources at Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination(Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination)
- Number of Participants with Serious adverse Events (SAE)(24 months)