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

1 augustus 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

217

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Autoinjector A
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
Geneesmiddel: 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.
Experimenteel: Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
Geneesmiddel: Etanercept via Autoinjector B
Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
Andere namen:
  • Enbrel® SureClick®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Needle Apprehension at Week 4
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amgen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 juni 2013

Primaire voltooiing (Werkelijk)

4 maart 2014

Studie voltooiing (Werkelijk)

4 maart 2014

Studieregistratiedata

Eerst ingediend

10 juni 2013

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2013

Eerst geplaatst (Schatting)

12 juni 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2018

Laatste update ingediend die voldeed aan QC-criteria

1 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20090176

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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