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Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

2018년 8월 1일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

217

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Alabama
      • Huntsville, Alabama, 미국, 35801
        • Research Site
      • Tuscaloosa, Alabama, 미국, 35406
        • Research Site
    • Arizona
      • Glendale, Arizona, 미국, 85304
        • Research Site
      • Scottsdale, Arizona, 미국, 85258
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, 미국, 71913
        • Research Site
    • California
      • San Diego, California, 미국, 92108
        • Research Site
      • San Ramon, California, 미국, 94583
        • Research Site
      • Santa Maria, California, 미국, 93454-6945
        • Research Site
      • Tustin, California, 미국, 92780
        • Research Site
    • Colorado
      • Denver, Colorado, 미국, 80230
        • Research Site
    • Florida
      • Dunedin, Florida, 미국, 34698
        • Research Site
      • Tampa, Florida, 미국, 33614
        • Research Site
    • Kansas
      • Overland Park, Kansas, 미국, 66215
        • Research Site
    • Kentucky
      • Louisville, Kentucky, 미국, 40217
        • Research Site
    • Maryland
      • Frederick, Maryland, 미국, 21702
        • Research Site
    • Michigan
      • Lansing, Michigan, 미국, 48910
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, 미국, 68516
        • Research Site
    • New York
      • Orchard Park, New York, 미국, 14127
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, 미국, 58502
        • Research Site
    • Ohio
      • Dayton, Ohio, 미국, 45417
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73103
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, 미국, 16635
        • Research Site
      • Wyomissing, Pennsylvania, 미국, 19610
        • Research Site
    • South Carolina
      • Charleston, South Carolina, 미국, 29414
        • Research Site
    • Tennessee
      • Hixson, Tennessee, 미국, 37343
        • Research Site
    • Texas
      • Austin, Texas, 미국, 78731
        • Research Site
      • Dallas, Texas, 미국, 75231
        • Research Site
    • West Virginia
      • Clarksburg, West Virginia, 미국, 26301
        • Research Site
  • 캐나다
    • British Columbia
      • Victoria, British Columbia, 캐나다, V8V 3P9
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, 캐나다, A1C 5B8
        • Research Site
    • Ontario
      • Barrie, Ontario, 캐나다, L4M 7G1
        • Research Site
      • Burlington, Ontario, 캐나다, L7R 1E2
        • Research Site
      • Courtice, Ontario, 캐나다, L1E 3C3
        • Research Site
      • Hamilton, Ontario, 캐나다, L8N 1Y2
        • Research Site
      • Mississauga, Ontario, 캐나다, L5M 2V8
        • Research Site
      • Oakville, Ontario, 캐나다, L6J 7W5
        • Research Site
      • Peterborough, Ontario, 캐나다, K9J 1Z2
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Autoinjector A
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
의약품: Etanercept via Autoinjector A
Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.
실험적: Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
의약품: Etanercept via Autoinjector B
Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
다른 이름들:
  • Enbrel® SureClick®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
기간: Week 8
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?"
Week 8

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Needle Apprehension at Week 4
기간: Baseline and Week 4
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).
Baseline and Week 4
Ease of Use
기간: At the end of each treatment period; Week 4 and Week 8
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.
At the end of each treatment period; Week 4 and Week 8
Certainty of Completing the Injection With the Autoinjector
기간: At the end of each treatment period; Week 4 and Week 8
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.
At the end of each treatment period; Week 4 and Week 8
Convenience
기간: At the end of each treatment period; Week 4 and Week 8
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.
At the end of each treatment period; Week 4 and Week 8
Discomfort
기간: At the end of each treatment period; Week 4 and Week 8
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.
At the end of each treatment period; Week 4 and Week 8
Satisfaction
기간: At the end of each treatment period; Week 4 and Week 8
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.
At the end of each treatment period; Week 4 and Week 8
Pain Associated With Use of the Autoinjector
기간: At the end of each treatment period; Week 4 and Week 8
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.
At the end of each treatment period; Week 4 and Week 8
Strength of Preference for Autoinjector A and Autoinjector B
기간: Week 8
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).
Week 8

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Amgen

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유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 6월 5일

기본 완료 (실제)

2014년 3월 4일

연구 완료 (실제)

2014년 3월 4일

연구 등록 날짜

최초 제출

2013년 6월 10일

QC 기준을 충족하는 최초 제출

2013년 6월 10일

처음 게시됨 (추정)

2013년 6월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 1일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20090176

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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