A One-year Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Crohn's Disease (CD) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 10
- 主要终点
- Number of Participants with Serious Adverse Events (SAEs)
研究概览
简要总结
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective Humira (adalimumab) is in treating moderately to severely active CD in China. Adverse events and change in disease activity will be assessed.
Humira (adalimumab) is a drug approved for the treatment of Crohn's disease (CD).All study participants will receive Humira as prescribed by their study doctor in accordance with approved local label. Approximately 252 participants will be enrolled in China.
Participants will receive subcutaneous HUMIRA (adalimumab) injection as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 1 year.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
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
- •Participants meet the diagnosis of moderate to severe Crohn's disease.
- •Participants prescribed with Humira, under investigators' sufficient consideration of benefits/ risks per local label.
排除标准
- •Participants who have any of the contraindications as per adalimumab (Humira) label in China.
- •Participants who are allergic to any component of adalimumab (Humira).
- •Participants with active hepatitis B diagnosed.
- •Participants with severe active infection, or known history of active or latent tuberculosis (TB), or latent TB infection with inadequate treatment.
- •Participants with cancer diagnosed, excluding also those with non-melanoma skin cancer (NMSC) completely treated, per local label.
- •Participants with moderate to severe heart failure.
- •Participants who are unwilling to participate, or not suitable for participation as judged by the investigator at risk of noncompliance to study procedure.
- •Participants who are enrolled to other interventional studies.
- •Participants who are prescribed with adalimumab but choose Humira bio-similar in China.
结局指标
主要结局
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Upto week 52
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
次要结局
- Number of Participants With Serious Adverse Drug Reaction (ADR)(Upto week 52)
- Number of Participants With Non-Serious Adverse Drug Reaction (ADR)(Upto week 52)
- Number of Participants who Achieved Clinical Remission Harvey-Bradshaw index (HBI)(Upto week 52)
- Number of Participants who Achieved Clinical Response Harvey-Bradshaw index (HBI)(Upto week 52)