An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Celltrion
- 入组人数
- 248
- 主要终点
- The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
研究概览
简要总结
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.
详细描述
This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.
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
- •Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria
排除标准
- •Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.
- •Patients with a current or past history of chronic infection
- •Patients with moderate or severe heart failure (NYHA class III/IV).
结局指标
主要结局
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
时间窗: Duration of study participation (up to 5 years)
* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion reactions associated with shortened infusion duration * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction
次要结局
- Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability(Day 0 ~ Week 198 (every 6 months ±6 weeks))
- Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)(Day 0 ~ Week 198 (every 6 months ±6 weeks))
