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临床试验/NCT02557295
NCT02557295终止不适用

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Rheumatoid Arthritis

Celltrion0 个研究点目标入组 248 人开始时间: 2013年12月17日最近更新:
适应症

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

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))

研究者

发起方
Celltrion
申办方类型
Industry
责任方
Sponsor

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