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Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept

1 augusti 2018 uppdaterad av: Amgen

A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept

The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept (Enbrel®).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a 4-week screening period and a 5-week treatment period.

Studietyp

Interventionell

Inskrivning (Faktisk)

77

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Huntsville, Alabama, Förenta staterna, 35801
        • Research Site
    • Arizona
      • Peoria, Arizona, Förenta staterna, 85381
        • Research Site
      • Phoenix, Arizona, Förenta staterna, 85037
        • Research Site
    • California
      • Santa Maria, California, Förenta staterna, 93454-6945
        • Research Site
      • Upland, California, Förenta staterna, 91786
        • Research Site
    • Colorado
      • Denver, Colorado, Förenta staterna, 80230
        • Research Site
    • Florida
      • Sarasota, Florida, Förenta staterna, 34239
        • Research Site
      • Tampa, Florida, Förenta staterna, 33614
        • Research Site
    • Kentucky
      • Paducah, Kentucky, Förenta staterna, 42003
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, Förenta staterna, 68516
        • Research Site
    • New York
      • Orchard Park, New York, Förenta staterna, 14127
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73103
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Förenta staterna, 16635
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on history.
  • Subject is willing to self-inject per investigator judgement at screening.
  • Subject has no known history of tuberculosis.

Exclusion Criteria:

  • Latex allergy.
  • Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first study 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Etanercept / Autoinjector A
Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
Läkemedel: Etanercept / Autoinjector A
Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).
Andra namn:
  • Enbrel®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Successful Self-injections to Total Non-missed Injections
Tidsram: Week 1, Week 2, Week 3, Week 4 and Week 5
The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.
Week 1, Week 2, Week 3, Week 4 and Week 5

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Autoinjector A System Failures
Tidsram: Week 1, Week 2, Week 3, Week 4 and Week 5
The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers. System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.
Week 1, Week 2, Week 3, Week 4 and Week 5
Percentage of Errors in Each Step of the Self-injection Process
Tidsram: Week 1, Week 2, Week 3, Week 4 and Week 5
For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported. If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not. • Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).
Week 1, Week 2, Week 3, Week 4 and Week 5

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events
Tidsram: 9 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study. The definition includes worsening of a pre-existing medical condition. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. An adverse device effect is any adverse event related to the use of a medical device. Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.
9 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Amgen

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 juni 2013

Primärt slutförande (Faktisk)

18 december 2013

Avslutad studie (Faktisk)

30 december 2013

Studieregistreringsdatum

Först inskickad

17 maj 2013

Först inskickad som uppfyllde QC-kriterierna

16 juli 2013

Första postat (Uppskatta)

17 juli 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20110107

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