Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Bialystok、波兰、15-099
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
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Bydgoszcz、波兰、85-168
- Szpital Uniwersytecki nr 2 im.dr J. Biziela
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Elblag、波兰、82-300
- Wojewodzki Szpital Zespolony w Elblagu
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Gdynia、波兰、81-338
- Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
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Katowice、波兰、40-954
- Medical Centre Pratia Katowice I
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Krakow、波兰、30-002
- Medical Centre Pratia Krakow
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Krakow、波兰、31-023
- Specialist Center ALL-MED, Krakow
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Torun、波兰、87-100
- Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
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Warszawa、波兰、01-868
- Medical Centre Pratia Warszawa
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Wroclaw、波兰、51-128
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
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California
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Upland、California、美国、91786
- Inland Rheumatology Clinical Trials, Inc.
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Florida
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Venice、Florida、美国、34292
- Lovelace Scientific Resources, Incorporated
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Maryland
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Cumberland、Maryland、美国、21502
- Klein and Associates, M.D., P.A.
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Massachusetts
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Worcester、Massachusetts、美国、01605
- Clinical Pharmacology Study Group
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New Mexico
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Albuquerque、New Mexico、美国、87102
- Albuquerque Center For Rheumatology
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Texas
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Dallas、Texas、美国、75231
- Metroplex Clinical Research Center
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Houston、Texas、美国、77065
- Rheumatology Clinic of Houston, P.A.
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Lubbock、Texas、美国、79424
- Arthritis & Osteoporosis Associates LLP
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Nassau Bay、Texas、美国、77058
- Heartland Research Associates, LLC
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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
描述
Inclusion criteria:
- Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which is not adequately controlled by non-biologics DMARDs.
- No contraindications to anti-Tumor necrosis factor (TNF) agents.
- Either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen.
- Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.
Exclusion criteria:
- Experience with self-administration of medication using an autoinjector or pen.
- American College of Rheumatology functional Class IV or wheelchair/ bed bound.
- Primary or secondary immunodeficiency.
- History of tuberculosis (TB). Further exclusion criteria apply.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：BI 695501
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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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Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections
大体时间：Up to Day 50.
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The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis. Percentage of injections calculated relative to the total number of first injections. |
Up to Day 50.
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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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Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
大体时间：Up to Day 50.
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The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c). Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful). |
Up to Day 50.
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Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
大体时间：Up to 17 weeks.
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Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set. |
Up to 17 weeks.
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Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
大体时间：Up to 17 weeks.
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A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication.
Data is reported for the autoinjector assessment period.
TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive.
The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included).
If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
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Up to 17 weeks.
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
大体时间：up to Week 60
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The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase.
In Extension phase, patients were given diaries to record events between each site visit during extension phase.
Patients were instructed to accurately record the following on the diary cards: the dates & times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions.
Patients were instructed to contact the site if they experienced any AEs between designated site visits.
In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
Percentage of subjects calculated relative to the total number of subjects in the analysis set
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up to Week 60
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
大体时间：up to Week 60
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The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase.
In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive.
The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included).
Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
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up to Week 60
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合作者和调查者
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 (实际的)
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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