An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent
2016年7月7日 更新者：Hoffmann-La Roche
Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program
This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy.
Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.
研究概览
研究类型
观察性的
注册 (实际的)
505
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bucuresti、罗马尼亚、020983
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Participants with active rheumatoid arthritis and an inadequate response or intolerant to one prior anti-TFN therapy initiated on treatment with MabThera/Rituxan
描述
Inclusion Criteria:
- Adult participants, >/= 18 years of age
- Participants with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with summary of product characteristics (SPC)
- Inadequate response to a single TNF inhibitor defined as change in disease activity score-28 erythrocyte sedimentation rate (DAS28-ESR) <1.2 or DAS28-ESR >3.5 at 5 months after first course of anti-TNF therapy
- Participants with a clinical and biological evaluation performed within 12 weeks prior to enrollment may be included
Exclusion Criteria:
- More than one previous anti-TNF therapies
- Any other biological therapy apart from the one anti-TNF therapy
- Hypersensitivity to rituximab or any of the excipients or to murine proteins
- Active severe infections
- Participants in a severely immunocompromised state
- Severe heart failure [New York Heart Association (NYHA) Class IV] or severe, uncontrolled cardiac disease
- Women of childbearing potential not willing to use contraception
- Pregnant or breastfeeding women
- Participation in another trial
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
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Rituximab
Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
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Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
其他名称：
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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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Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria
大体时间：Week 20
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The DAS28 score is a measure of the participant's disease activity.
It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR.
DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity.
A negative change from Baseline indicates improvement.
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached.
Good response: DAS28 <=3.2 and a CFB >1.2.
Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2.
No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
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Week 20
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Change From Baseline in DAS28-ESR at Week 20
大体时间：Baseline and Week 20
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DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity [measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity].
DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity.
Total score range: 0-10, with a higher score indicated more disease activity.
DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
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Baseline and Week 20
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Mean DAS28-ESR Score at Visit 4 (Week 20)
大体时间：Week 20
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DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity).
DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity.
Total score range: 0-10, with a higher score indicated more disease activity.
DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
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Week 20
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Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment
大体时间：Week 20
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DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity).
DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity.
Total score range: 0-10, with a higher score indicated more disease activity.
DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
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Week 20
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Percentage of Participants With EULAR Response
大体时间：Week 20
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The DAS28 score is a measure of the participant's disease activity.
It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR.
DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity.
A negative CFB indicates improvement.
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached.
Good response: DAS28 <=3.2 and a CFB >1.2.
Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2.
No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
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Week 20
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Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously
大体时间：Week 20
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The DAS28 score is a measure of the participant's disease activity.
It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR.
DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity.
A negative CFB indicates improvement.
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached.
Good response: DAS28 <=3.2 and a CFB >1.2.
Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2.
No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
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Week 20
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Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course
大体时间：Week 20
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DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity).
DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity.
Total score range: 0-10, with a higher score indicated more disease activity.
DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
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Week 20
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Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab
大体时间：Week 20
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The DAS28 score is a measure of the participant's disease activity.
It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR.
DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity.
A negative change from Baseline (CFB) indicates improvement.
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached.
Good response: DAS28 <=3.2 and a CFB >1.2.
Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2.
No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
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Week 20
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Number of Participants With Adverse Events (AE)
大体时间：Up to 39 months
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An AE was defined as 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 considered related to the medicinal product.
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Up to 39 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health Assessment Questionnaire (HAQ) Score at Week 20
大体时间：Baseline and Week 20
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HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA).
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities.
Each domain has at least 2 component questions.
There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do.
Calculate HAQ the patient must have a domain score for at least 6 of 8 domains.
The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst).
A negative change from baseline indicated improvement.
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Baseline and Week 20
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年10月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2012年7月13日
首先提交符合 QC 标准的
2012年7月13日
首次发布 (估计)
2012年7月17日
研究记录更新
最后更新发布 (估计)
2016年8月17日
上次提交的符合 QC 标准的更新
2016年7月7日
最后验证
2016年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.