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Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe

12 giugno 2018 aggiornato da: Boehringer Ingelheim

Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe

This is an open-label, phase II study of BI 695501 to assess handling experience of patients with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients with additional exposure to BI 695501 and to enhance the safety database for this compound.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

77

Fase

  • Fase 2

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

  • Polonia
      • Bialystok, Polonia, 15-099
        • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
      • Bydgoszcz, Polonia, 85-168
        • Szpital Uniwersytecki nr 2 im.dr J. Biziela
      • Elblag, Polonia, 82-300
        • Wojewodzki Szpital Zespolony w Elblagu
      • Gdynia, Polonia, 81-338
        • Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
      • Katowice, Polonia, 40-954
        • Medical Centre Pratia Katowice I
      • Krakow, Polonia, 30-002
        • Medical Centre Pratia Krakow
      • Krakow, Polonia, 31-023
        • Specialist Center ALL-MED, Krakow
      • Torun, Polonia, 87-100
        • Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
      • Warszawa, Polonia, 01-868
        • Medical Centre Pratia Warszawa
      • Wroclaw, Polonia, 51-128
        • Wojewodzki Szpital Specjalistyczny We Wroclawiu
  • Stati Uniti
    • California
      • Upland, California, Stati Uniti, 91786
        • Inland Rheumatology Clinical Trials, Inc.
    • Florida
      • Venice, Florida, Stati Uniti, 34292
        • Lovelace Scientific Resources, Incorporated
    • Maryland
      • Cumberland, Maryland, Stati Uniti, 21502
        • Klein and Associates, M.D., P.A.
    • Massachusetts
      • Worcester, Massachusetts, Stati Uniti, 01605
        • Clinical Pharmacology Study Group
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87102
        • Albuquerque Center for Rheumatology
    • Texas
      • Dallas, Texas, Stati Uniti, 75231
        • Metroplex Clinical Research Center
      • Houston, Texas, Stati Uniti, 77065
        • Rheumatology Clinic of Houston, P.A.
      • Lubbock, Texas, Stati Uniti, 79424
        • Arthritis & Osteoporosis Associates LLP
      • Nassau Bay, Texas, Stati Uniti, 77058
        • Heartland Research Associates, LLC

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

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria:

  • Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which is not adequately controlled by non-biologics DMARDs.
  • No contraindications to anti-Tumor necrosis factor (TNF) agents.
  • Either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen.
  • Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.

Exclusion criteria:

  • Experience with self-administration of medication using an autoinjector or pen.
  • American College of Rheumatology functional Class IV or wheelchair/ bed bound.
  • Primary or secondary immunodeficiency.
  • History of tuberculosis (TB). Further exclusion criteria 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: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: BI 695501
Droga: BI 695501 Autoinjector
Droga: BI 695501 Prefilled syringe

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections
Lasso di tempo: Up to Day 50.

The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis.

Percentage of injections calculated relative to the total number of first injections.
Up to Day 50.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
Lasso di tempo: Up to Day 50.

The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c).

Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful).
Up to Day 50.
Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
Lasso di tempo: Up to 17 weeks.

Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.

Percentage of subjects calculated relative to the total number of subjects in the analysis set.
Up to 17 weeks.
Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
Lasso di tempo: Up to 17 weeks.
A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication. Data is reported for the autoinjector assessment period. TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
Up to 17 weeks.
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
Lasso di tempo: up to Week 60
The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase. In Extension phase, patients were given diaries to record events between each site visit during extension phase. Patients were instructed to accurately record the following on the diary cards: the dates & times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions. Patients were instructed to contact the site if they experienced any AEs between designated site visits. In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set
up to Week 60
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
Lasso di tempo: up to Week 60
The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase. In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive. The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included). Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
up to Week 60

Collaboratori e investigatori

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

Sponsor

Boehringer Ingelheim

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.

Pubblicazioni generali

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)

6 gennaio 2016

Completamento primario (Effettivo)

21 giugno 2016

Completamento dello studio (Effettivo)

29 giugno 2017

Date di iscrizione allo studio

Primo inviato

18 dicembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

18 dicembre 2015

Primo Inserito (Stima)

22 dicembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2018

Ultimo verificato

1 giugno 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1297.11
  • 2015-003030-27 (Numero EudraCT)

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 .

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