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Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

22. januar 2019 oppdatert av: Hoffmann-La Roche

Tocilizumab Real-Life Human Factors Validation Study

This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

91

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Mesa, Arizona, Forente stater, 85202
        • Arizona Arthritis and Rheuma
    • California
      • Los Alamitos, California, Forente stater, 90720
        • Valerius Medical Group & Research Ctr of Greater Long Beach
      • Santa Maria, California, Forente stater, 93454
        • Pacific Arthritis Ctr Med Grp
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40515
        • Bluegrass Comm Research, Inc.
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • Oklahoma Center For Arthritis Therapy & Research
    • Pennsylvania
      • Duncansville, Pennsylvania, Forente stater, 16635
        • Altoona Center For Clinical Research
      • Wexford, Pennsylvania, Forente stater, 15090
        • Advanced Rheumatology & Arthritis Research Center
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Metroplex Clinical Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participants with RA for greater than or equal to (>/=6) months receiving 162 mg tocilizumab PFS-NSD for >/=8 weeks and who are suitable for continued treatment at their currently prescribed dose
  • CGs and professionally qualified HCPs who are able and willing to administer the injection

Exclusion Criteria:

  • RA: Functional status Class IV
  • RA: Neuropathies or other conditions that might interfere with pain evaluation
  • RA: Pregnant or breastfeeding
  • RA: Low neutrophil or platelet count at last laboratory assessment
  • RA: Elevated liver enzymes at last laboratory assessment
  • Current participation in another interventional clinical trial
  • Criteria that might give the participant/CG/HCP an advantage in injection tasks such as employment in the pharmaceutical industry, etc.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Caregivers
CGs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
Enhet: AI-1000 G2
Tocilizumab will be administered using the AI-1000 G2.
Legemiddel: Tocilizumab
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Andre navn:
  • Actemra/RoActemra, RO4877533
Eksperimentell: Healthcare Professionals
HCPs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
Enhet: AI-1000 G2
Tocilizumab will be administered using the AI-1000 G2.
Legemiddel: Tocilizumab
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Andre navn:
  • Actemra/RoActemra, RO4877533
Eksperimentell: RA Group 1 (Self-Administration)
Participants with RA will perform self-injection of SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
Enhet: AI-1000 G2
Tocilizumab will be administered using the AI-1000 G2.
Legemiddel: Tocilizumab
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Andre navn:
  • Actemra/RoActemra, RO4877533
Annen: RA Group 2 (Administration by CG)
CGs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.
Enhet: AI-1000 G2
Tocilizumab will be administered using the AI-1000 G2.
Legemiddel: Tocilizumab
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Andre navn:
  • Actemra/RoActemra, RO4877533
Annen: RA Group 3 (Administration by HCP)
HCPs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visit 1 (Day 0) will be performed by the study nurse. Visits 2 and 3 (Days 14 and 28) will be conducted by the HCP for use/performance evaluation.
Enhet: AI-1000 G2
Tocilizumab will be administered using the AI-1000 G2.
Legemiddel: Tocilizumab
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Andre navn:
  • Actemra/RoActemra, RO4877533

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Tidsramme: Day 14
Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the first unassisted use (Day 14) was reported.
Day 14
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Tidsramme: Day 28
Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the second unassisted use (Day 28) was reported.
Day 28

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
Tidsramme: Days 14, 28
Ancillary tasks included those tasks where the potential harm resulting from use error would be minor in severity, or the resultant harms were estimated to occur at sufficiently low levels. Ancillary tasks included the following: wash hands; clean the injection site with alcohol swab; wait for the alcohol to dry; dispose of the autoinjector cap; inspect full dose delivered after use; dispose of the autoinjector; and treatment of injection site after injection. The percentage of participants who succesffully performed ancillary tasks during the first (Day 14) and second unassisted use (Day 28) was reported.
Days 14, 28
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
Tidsramme: 0 and 15 minutes after injection on Days 0, 14, 28
Injection pain was assessed on a continuous 100-millimeter (mm) VAS, where 0 mm represents "no pain" and 100 mm represents "unbearable pain". The mean VAS response at each assessment timepoint was reported among participants with RA.
0 and 15 minutes after injection on Days 0, 14, 28
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
Tidsramme: 0 and 15 minutes after injection on Days 0, 14, 28
Injection pain was assessed on a categorical 6-point Likert scale, ranging from "no pain" to "severe and intolerable". The percentage of participants was reported by response at each assessment timepoint among participants with RA.
0 and 15 minutes after injection on Days 0, 14, 28
Percentage of Participants by Response to Device Satisfaction Questionnaire
Tidsramme: Days 0, 14, 28
Device satisfaction was assessed using twelve questions on a categorical 5-point Likert scale, ranging from "strongly agree" to "strongly disagree". Question (Q) 1 (felt the autoinjection was easy to use), Q2 (felt comfortable while using the autoinjector), Q3 (felt the autoinjector was easy to hold), Q4 (able to tell when injection had completed), Q5 (felt he/she can inject properly with the autoinjector), Q6 (felt he/she had control over the injection process), Q7 (felt confident that he/she injected successfully), Q8 (felt it is easy to dispose of the autoinjector), Q9 (autoinjector would help to manage his/her injection schedule), Q10 (liked the look/feel of the autoinjector), Q11 (would recommend the autoinjector to someone else who needed to inject), Q12 (would continue having injections with the autoinjector). The percentage of participants was reported by response at each assessment among participants with RA, CGs, and HCPs.
Days 0, 14, 28
Tender Joint Count (TJC) Among Participants With RA
Tidsramme: Baseline (Day 0)
Sixty-eight joints were assessed for tenderness among participants with RA. The number of tender joints at Baseline was reported.
Baseline (Day 0)
Swollen Joint Count (SJC) Among Participants With RA
Tidsramme: Baseline (Day 0)
Sixty-six joints were assessed for swelling among participants with RA. The number of swollen joints at Baseline was reported.
Baseline (Day 0)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
Tidsramme: Days 0, 14, 28
Ability to perform daily living activities was assessed across eight component sets including dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Twenty questions were scored on a 4-point Likert scale from 0 meaning "without any difficulty" to 3 meaning "unable to do". The overall score was computed as the sum of domain scores divided by the number of domains answered. Therefore, the score range for HAQ-DI was the same as that of the individual questions, that is, from 0 to 3, where 0 indicates "least difficulty" and 3 indicates "extreme difficulty". The mean change from baseline in HAQ-DI at each assessment was reported among participants with RA.
Days 0, 14, 28

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. mars 2016

Primær fullføring (Faktiske)

29. juli 2016

Studiet fullført (Faktiske)

29. juli 2016

Datoer for studieregistrering

Først innsendt

11. februar 2016

Først innsendt som oppfylte QC-kriteriene

11. februar 2016

Først lagt ut (Anslag)

15. februar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • WA29917

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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