Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
Post-marketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA® (Adalimumab SC) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.
Exclusion Criteria:
- Hypersensitivity against the drug or one of the other ingredients.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Participants with Crohn's Disease (CD)
Participants with Crohn's Disease treated with adalimumab (HUMIRA®) in routine clinical practice.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit
大体时间:Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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The CDAI is a measure of clinical response and remission that was developed for use in clinical trials.
The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables.
For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week.
Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score.
Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit.
The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease.
Negative changes indicate reductions (improvement) in disease activity.
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Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time
大体时间:Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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The CDAI is a measure of clinical response and remission that was developed for use in clinical trials.
The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables.
For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week.
Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score.
Higher CDAI scores indicate greater disease activity; there is no set upper limit.
The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease.
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Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants
大体时间:Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD.
The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL).
The individual sub scores are added to produce the total SIBDQ score.
SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL.
Positive changes indicate reductions in disease activity.
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Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)
大体时间:Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. For more details on adverse events please see the AE section below. |
Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time
大体时间:Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores.
The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables.
Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI.
The total HBI score is the sum of the values for each of the five items.
Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit.
Scores < 5 indicate remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease.
Each HBI unit is equivalent to approximately 27 CDAI units.
Higher scores indicate greater disease activity.
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Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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Compliance With the Self-injection Via the Humira®-PEN
大体时间:Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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Adalimumab will be self-administered by participants using Humira®-PEN.
Analysis of compliance was not performed as outlined in the protocol.
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Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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合作者和调查者
调查人员
- 研究主任:Sandra Bloch, MD、AbbVie Deutschland GmbH & Co. KG, Medical Department
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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