Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 193
- 主要终点
- Number of Participants With Adverse Drug Reactions
研究概览
简要总结
This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:
- Unknown adverse drug reactions (especially important adverse drug reactions)
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Humira
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
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey
排除标准
- •Contraindications according to the Package Insert
- •Patients who have serious infections
- •Patients who have tuberculosis
- •Patients with a history of hypersensitivity to any ingredient of Humira
- •Patients who have demyelinating disease or with a history of demyelinating disease
- •Patients who have congestive cardiac failure
结局指标
主要结局
Number of Participants With Adverse Drug Reactions
时间窗: 24 weeks
An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. A serious adverse drug reaction is any untoward medical occurrence that at any dose; * Results in death * Life threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent of significant disability or incapacity
Number of Participants With Adverse Drug Reactions by Baseline Factors
时间窗: 24 weeks
An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics. NSAID: non-steroidal anti-inflammatory drug DMARD: disease-modifying anti-rheumatic drug BASDAI: Bath Ankylosing Spondylitis Disease Activity Index
Number of Participants With Self-injection Errors
时间窗: 24 weeks
Number of Participants With Adverse Events
时间窗: 24 weeks
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
次要结局
- Number of Participants With Markedly Improved or Improved Rating(Weeks 12, 24, and at the last visit)
- Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors(24 weeks (or last visit if earlier))
- Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline and weeks 12 and 24)