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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. Juni 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

77

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: BI 695501
Arzneimittel: BI 695501 Autoinjector
Arzneimittel: BI 695501 Prefilled syringe

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Januar 2016

Primärer Abschluss (Tatsächlich)

21. Juni 2016

Studienabschluss (Tatsächlich)

29. Juni 2017

Studienanmeldedaten

Zuerst eingereicht

18. Dezember 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Dezember 2015

Zuerst gepostet (Schätzen)

22. Dezember 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2018

Zuletzt verifiziert

1. Juni 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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