An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Celltrion
- 入组人数
- 329
- 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 Ankylosing Spondylitis
详细描述
This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with AS in comparison with patients receiving other TNF blockers. 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. 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. For switched patients, their assessment schedule will be re-started from the day of switch. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.
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 AS
- •Patients who meet the following conditions can be enrolled:
- •i) The RemsimaTM cohort will include all patients who will start RemsimaTM at the time of enrolment in accordance to the approved product label ii) Patients who have started to be treated with an established anti -TNF such as Infliximab (Remicade®), Etanercept, Adalimumab and etc. within 6 months
- •Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of RemsimaTM.
- •Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records
排除标准
- •Patients with a history of hypersensitivity to infliximab
- •Patients with a current or past history of chronic infection
- •Current diagnosis of TB or severe or chronic infections (e.g. sepsis, abscess or opportunistic infections or invasive fungal infections), or a past diagnosis of TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
- •Recent exposure to persons with active TB, or a positive test result for latent TB (defined as a positive interferon-γ release assay [IGRA] with a negative examination of chest X-ray) at Screening.
- •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 related reaction (IRR)/hypersensitivity/anaphylactic reaction
次要结局
- The Number and Percentage of Patients Achieving BASDAI 50(Month 6 ~ Month 48 (every 6 months ± 6 weeks))
- Descriptive Statistics for BASFI(Day 0 ~ Month 48 (every 6 months ± 6 weeks))
- Descriptive Statistics of Physician Global Assessment Score(Day 0 ~ Month 48 (every 6 months ±6 weeks))
- Descriptive Statistics of Patient Global Assessment Score(Day 0 ~ Month 48 (every 6 months ±6 weeks))
- Descriptive Statistics of Spinal Pain Score(Day 0 ~ Month 48 (every 6 months ±6 weeks))