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Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

10. Mai 2013 aktualisiert von: Amgen
This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

468

Phase

  • Phase 3

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 und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria: - Previous enrollment in Immunex protocol 016.0012.

  • No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
  • Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
  • No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria:
  • Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
  • Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study.
  • Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
  • Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: 1
Biologisch: Etanercept
Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total Exposure to Etanercept With Gaps
Zeitfenster: Up to 8 years
Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
Up to 8 years
Total Exposure-Adjusted Rate of Malignancies
Zeitfenster: Up to 8 years
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Up to 8 years
Total Exposure-Adjusted Rate of Deaths
Zeitfenster: Up to 8 years
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Up to 8 years
Total Exposure Adjusted Rate of Serious Infectious Events
Zeitfenster: Up to 8 years
Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
Up to 8 years
Total Exposure Adjusted Rate of Lymphomas
Zeitfenster: Up to 8 years
Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Up to 8 years
Malignancy
Zeitfenster: Up to 8 years
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
Up to 8 years
Lymphoma
Zeitfenster: Up to 8 years
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Up to 8 years
Serious Infectious Event
Zeitfenster: Up to 8 years
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication
Up to 8 years
Total Exposure Adjusted Rate of Serious Adverse Events
Zeitfenster: Up to 8 years
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
Up to 8 years
Death
Zeitfenster: Up to 8 years
Death of the participant on study up to 30 days after the last dose of etanercept
Up to 8 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
ACR20 Response at Month 3
Zeitfenster: Baseline and month 3
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)
Baseline and month 3
Dosing Period
Zeitfenster: Up to 8 years
Duration of etanercept dosing
Up to 8 years
ACR20 Response at Month 12
Zeitfenster: Baseline and month 12
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Baseline and month 12
ACR50 Response at Month 12
Zeitfenster: Baseline and month 12
American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Baseline and month 12
ACR70 Response at Month 12
Zeitfenster: Baseline and month 12
American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Baseline and month 12
Standardized Incidence Rate for All SEER Cancers
Zeitfenster: Up to 8 years
Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.
Up to 8 years
Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
Baseline and month 12
Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
Zeitfenster: Baseline and Month 12
Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
Baseline and Month 12
Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm).
Baseline and month 12
Percent Improvement in Tender Joint Count From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.
Baseline and month 12
Percent Improvement in Swollen Joint Count From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.
Baseline and month 12
Percent Improvement in HAQ DI From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.
Baseline and month 12
Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
Baseline and month 12
Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
Baseline and month 12
Percent Improvement in C-Reactive Protein From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in C-reactive protein from baseline to month 12
Baseline and month 12
Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12
Zeitfenster: Baseline and month 12
Percent improvement in the duration of morning stiffness from baseline to month 12
Baseline and month 12
Change From Baseline to Year 2 in Total Sharp Score
Zeitfenster: Baseline, Year 2
Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.
Baseline, Year 2
Change From Baseline to Year 2 in Sharp Score Erosion Subscale
Zeitfenster: Baseline, Year 2
Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.
Baseline, Year 2
Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
Zeitfenster: Baseline, Year 2
Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.
Baseline, Year 2

Mitarbeiter und Ermittler

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

Sponsor

Amgen

Mitarbeiter

Immunex Corporation

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

1. Dezember 1998

Primärer Abschluss (Tatsächlich)

1. Dezember 2008

Studienabschluss (Tatsächlich)

1. April 2009

Studienanmeldedaten

Zuerst eingereicht

24. Juli 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juli 2006

Zuerst gepostet (Schätzen)

26. Juli 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

14. Mai 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Mai 2013

Zuletzt verifiziert

1. Mai 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20021623
  • 16.0023

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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