Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
2018年8月1日 更新者：Amgen
An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept
The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.
調査の概要
詳細な説明
Candidates for treatment are those who in the determination of the investigator's standard of care and the caring physician's intent are to initiate treatment with etanercept.
Participants must be naïve to etanercept and naïve to other autoinjector pens or prefilled syringes and be able to self-inject.
The study will consist of a 30 day screening period, and 2 treatment periods of 4 weeks duration each (one treatment period using Autoinjector A and the other using Autoinjector B).
At the end of the study, participants may continue treatment with commercially available etanercept at the physician's discretion.
研究の種類
介入
入学 (実際)
217
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Huntsville、Alabama、アメリカ、35801
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Tuscaloosa、Alabama、アメリカ、35406
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Arizona
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Glendale、Arizona、アメリカ、85304
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Scottsdale、Arizona、アメリカ、85258
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Arkansas
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Hot Springs、Arkansas、アメリカ、71913
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California
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San Diego、California、アメリカ、92108
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San Ramon、California、アメリカ、94583
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Santa Maria、California、アメリカ、93454-6945
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Tustin、California、アメリカ、92780
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Colorado
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Denver、Colorado、アメリカ、80230
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Florida
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Dunedin、Florida、アメリカ、34698
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Tampa、Florida、アメリカ、33614
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Kansas
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Overland Park、Kansas、アメリカ、66215
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Kentucky
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Louisville、Kentucky、アメリカ、40217
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Maryland
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Frederick、Maryland、アメリカ、21702
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Michigan
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Lansing、Michigan、アメリカ、48910
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Nebraska
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Lincoln、Nebraska、アメリカ、68516
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New York
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Orchard Park、New York、アメリカ、14127
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North Dakota
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Bismarck、North Dakota、アメリカ、58502
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Ohio
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Dayton、Ohio、アメリカ、45417
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73103
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Pennsylvania
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Duncansville、Pennsylvania、アメリカ、16635
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Wyomissing、Pennsylvania、アメリカ、19610
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South Carolina
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Charleston、South Carolina、アメリカ、29414
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Tennessee
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Hixson、Tennessee、アメリカ、37343
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Texas
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Austin、Texas、アメリカ、78731
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Dallas、Texas、アメリカ、75231
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West Virginia
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Clarksburg、West Virginia、アメリカ、26301
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British Columbia
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Victoria、British Columbia、カナダ、V8V 3P9
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、カナダ、A1C 5B8
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Ontario
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Barrie、Ontario、カナダ、L4M 7G1
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Burlington、Ontario、カナダ、L7R 1E2
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Courtice、Ontario、カナダ、L1E 3C3
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Hamilton、Ontario、カナダ、L8N 1Y2
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Mississauga、Ontario、カナダ、L5M 2V8
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Oakville、Ontario、カナダ、L6J 7W5
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Peterborough、Ontario、カナダ、K9J 1Z2
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous biologics for RA. - Willing to self-inject per investigator judgement at screening and capable of self-injection using the autoinjector A or B as documented at baseline by the investigator. - Able to read and write in English. -
Exclusion Criteria: Latex allergy. - Subject has an active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept. - Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
- Other criteria may apply.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：Autoinjector A
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
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Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.
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実験的：Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
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Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
他の名前：
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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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Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
時間枠：Week 8
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Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question "Which autoinjector do you prefer overall?"
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Week 8
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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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Change From Baseline in Needle Apprehension at Week 4
時間枠：Baseline and Week 4
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Participants' needle apprehension was assessed using the Subject's Perception of Self-Injecting Questionnaire.
Participants answered the question "Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector" using a scale from 1 (extremely nervous) to 5 (not at all nervous).
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Baseline and Week 4
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Ease of Use
時間枠：At the end of each treatment period; Week 4 and Week 8
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Ease of use was assessed based on responses to questions 1 to 6 of the Subject's Experience with the Autoinjector Questionnaire: 1.
How easy was it to learn how to use the autoinjector?
2. How easy was it for you to press the button to start the injection?
3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection?
5. How easy was it for you to inject yourself using the autoinjector?
6.
How easy was it to follow the progress of the injection?
Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy).
The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.
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At the end of each treatment period; Week 4 and Week 8
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Certainty of Completing the Injection With the Autoinjector
時間枠：At the end of each treatment period; Week 4 and Week 8
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Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject's Experience with the Autoinjector Questionnaire: "How certain were you that you knew when the injection was finished?"
Participants answered on a scale from 1 (Not at all) to 5 (Extremely).
The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Convenience
時間枠：At the end of each treatment period; Week 4 and Week 8
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Convenience was assessed based on responses to Question 8 of the Subject's Experience with the Autoinjector Questionnaire: "How convenient was the autoinjector to use?" Participants answered on a scale from 1 (Not at all) to 5 (Very much).
The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Discomfort
時間枠：At the end of each treatment period; Week 4 and Week 8
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Discomfort was assessed based on responses to Question 9 of the Subject's Experience with the Autoinjector Questionnaire: "How much discomfort did you experience when giving yourself the medicine using the autoinjector?"
Participants answered on a scale from 1 (None) to 5 (Very much).
The percentage of participants who scored a 1 (None) or 2 (A little) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Satisfaction
時間枠：At the end of each treatment period; Week 4 and Week 8
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Satisfaction was assessed based on responses to questions 11 and 12 of the Subject's Experience with the Autoinjector Questionnaire.
Question 11: "How dependable (durable, sturdy, reliable) did you feel the autoinjector device was?" answered on a scale from 1 (Not at all) to 5 (Very much).
Question 12: "Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept?" answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend).
The percentage of participants who scored either a 4 or 5 on each question is reported.
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At the end of each treatment period; Week 4 and Week 8
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Pain Associated With Use of the Autoinjector
時間枠：At the end of each treatment period; Week 4 and Week 8
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Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject's Experience with the Autoinjector Questionnaire: "Using this scale, select the circle that best describes how much it hurt when giving yourself an injection."
Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst).
The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Strength of Preference for Autoinjector A and Autoinjector B
時間枠：Week 8
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Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8.
After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).
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Week 8
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年6月5日
一次修了 (実際)
2014年3月4日
研究の完了 (実際)
2014年3月4日
試験登録日
最初に提出
2013年6月10日
QC基準を満たした最初の提出物
2013年6月10日
最初の投稿 (見積もり)
2013年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月4日
QC基準を満たした最後の更新が送信されました
2018年8月1日
最終確認日
2018年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。