Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

1 agosto 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

217

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Stati Uniti
    • Alabama
      • Huntsville, Alabama, Stati Uniti, 35801
        • Research Site
      • Tuscaloosa, Alabama, Stati Uniti, 35406
        • Research Site
    • Arizona
      • Glendale, Arizona, Stati Uniti, 85304
        • Research Site
      • Scottsdale, Arizona, Stati Uniti, 85258
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, Stati Uniti, 71913
        • Research Site
    • California
      • San Diego, California, Stati Uniti, 92108
        • Research Site
      • San Ramon, California, Stati Uniti, 94583
        • Research Site
      • Santa Maria, California, Stati Uniti, 93454-6945
        • Research Site
      • Tustin, California, Stati Uniti, 92780
        • Research Site
    • Colorado
      • Denver, Colorado, Stati Uniti, 80230
        • Research Site
    • Florida
      • Dunedin, Florida, Stati Uniti, 34698
        • Research Site
      • Tampa, Florida, Stati Uniti, 33614
        • Research Site
    • Kansas
      • Overland Park, Kansas, Stati Uniti, 66215
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40217
        • Research Site
    • Maryland
      • Frederick, Maryland, Stati Uniti, 21702
        • Research Site
    • Michigan
      • Lansing, Michigan, Stati Uniti, 48910
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68516
        • Research Site
    • New York
      • Orchard Park, New York, Stati Uniti, 14127
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, Stati Uniti, 58502
        • Research Site
    • Ohio
      • Dayton, Ohio, Stati Uniti, 45417
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73103
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Stati Uniti, 16635
        • Research Site
      • Wyomissing, Pennsylvania, Stati Uniti, 19610
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29414
        • Research Site
    • Tennessee
      • Hixson, Tennessee, Stati Uniti, 37343
        • Research Site
    • Texas
      • Austin, Texas, Stati Uniti, 78731
        • Research Site
      • Dallas, Texas, Stati Uniti, 75231
        • Research Site
    • West Virginia
      • Clarksburg, West Virginia, Stati Uniti, 26301
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Autoinjector A
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
Droga: 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.
Sperimentale: Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
Droga: Etanercept via Autoinjector B
Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
Altri nomi:
  • Enbrel® SureClick®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Needle Apprehension at Week 4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 giugno 2013

Completamento primario (Effettivo)

4 marzo 2014

Completamento dello studio (Effettivo)

4 marzo 2014

Date di iscrizione allo studio

Primo inviato

10 giugno 2013

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2013

Primo Inserito (Stima)

12 giugno 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20090176

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Etanercept via Autoinjector A

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Malawi

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi