Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima®
研究概览
简要总结
The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with rheumatoid arthritis(RA) in Jordan where no visits or intervention(s) additional to the daily practice will be performed
详细描述
A multi-center, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in patients with rheumatoid arthritis in Jordan. Biologic naïve patients will receive Remsima® in accordance with standard medical care and the approved label and will be followed over a period of 34 weeks (8.5 months). Outcomes including occurrence of adverse events (AEs), mean changes in disease activity and health assessment in each cohort will be measured and compared
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
- •Adult patients (age ≥18 years)
- •Biologic naïve patients with active RA diagnosed according to the revised 1987 American College of Rheumatology (ACR) (Arnett et al. 1988) or 2010 ACR / European League Against Rheumatism (EULAR) Rheumatoid Arthritis classification criteria (Aletaha et al. 2010)
- •Patients should be receiving a stable dose Methotrexate (MTX) for at least 3 months prior to enrolment, and still have active disease defined as erythrocyte sedimentation rate (ESR) ≥28 mm/h and swollen and tender joints ≥ 6
- •Absence of tuberculosis demonstrated by negative chest X-ray
排除标准
- •Patient <18 years
- •Previous treatment with biologics
- •Patients who meet any of the contraindications to the administration of infliximab
- •Previous or concurrent malignancies
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima®
时间窗: 8.5 months
Rate of AEs leading to permanent treatment discontinuation and rate of clinically relevant changes in laboratory tests will be calculated
次要结局
- Mean changes in disease activity scores (DAS28)-ESR (Erythrocyte Sedimentation Rate)(8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses)
- Mean changes in disease activity scores (DAS28)- Number of swollen joints(8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses)
- Mean changes in disease activity scores (DAS28)-Number of tender joints(8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses)
- Mean changes in disease activity scores (DAS28)- Global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS)(8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses)
- Mean changes in Disability Index of the Health Assessment Questionnaire (HAQ-DI)(8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses)