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

10 mei 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

468

Fase

  • Fase 3

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Exposure to Etanercept With Gaps
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 8 years
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
Up to 8 years
Death
Tijdsspanne: Up to 8 years
Death of the participant on study up to 30 days after the last dose of etanercept
Up to 8 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
ACR20 Response at Month 3
Tijdsspanne: 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
Tijdsspanne: Up to 8 years
Duration of etanercept dosing
Up to 8 years
ACR20 Response at Month 12
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amgen

Medewerkers

Immunex Corporation

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 1998

Primaire voltooiing (Werkelijk)

1 december 2008

Studie voltooiing (Werkelijk)

1 april 2009

Studieregistratiedata

Eerst ingediend

24 juli 2006

Eerst ingediend dat voldeed aan de QC-criteria

24 juli 2006

Eerst geplaatst (Schatting)

26 juli 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

14 mei 2013

Laatste update ingediend die voldeed aan QC-criteria

10 mei 2013

Laatst geverifieerd

1 mei 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20021623
  • 16.0023

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