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
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Upland、California、アメリカ、91786
- Inland Rheumatology Clinical Trials, Inc.
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Florida
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Venice、Florida、アメリカ、34292
- Lovelace Scientific Resources, Incorporated
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Maryland
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Cumberland、Maryland、アメリカ、21502
- Klein and Associates, M.D., P.A.
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Massachusetts
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Worcester、Massachusetts、アメリカ、01605
- Clinical Pharmacology Study Group
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New Mexico
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Albuquerque、New Mexico、アメリカ、87102
- Albuquerque Center For Rheumatology
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Texas
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Dallas、Texas、アメリカ、75231
- Metroplex Clinical Research Center
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Houston、Texas、アメリカ、77065
- Rheumatology Clinic of Houston, P.A.
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Lubbock、Texas、アメリカ、79424
- Arthritis & Osteoporosis Associates LLP
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Nassau Bay、Texas、アメリカ、77058
- Heartland Research Associates, LLC
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Bialystok、ポーランド、15-099
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
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Bydgoszcz、ポーランド、85-168
- Szpital Uniwersytecki nr 2 im.dr J. Biziela
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Elblag、ポーランド、82-300
- Wojewodzki Szpital Zespolony w Elblagu
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Gdynia、ポーランド、81-338
- Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
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Katowice、ポーランド、40-954
- Medical Centre Pratia Katowice I
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Krakow、ポーランド、30-002
- Medical Centre Pratia Krakow
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Krakow、ポーランド、31-023
- Specialist Center ALL-MED, Krakow
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Torun、ポーランド、87-100
- Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
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Warszawa、ポーランド、01-868
- Medical Centre Pratia Warszawa
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Wroclaw、ポーランド、51-128
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：BI 695501
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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