Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
10. maj 2013 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
468
Fase
- Fase 3
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 1
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Exposure to Etanercept With Gaps
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 8 years
|
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
|
Up to 8 years
|
|
Death
Tidsramme: Up to 8 years
|
Death of the participant on study up to 30 days after the last dose of etanercept
|
Up to 8 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ACR20 Response at Month 3
Tidsramme: 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
Tidsramme: Up to 8 years
|
Duration of etanercept dosing
|
Up to 8 years
|
|
ACR20 Response at Month 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18.
- Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1232-42.
- Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW, Spencer-Green G, Finck BK. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50. doi: 10.1002/art.10308.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 1998
Primær færdiggørelse (Faktiske)
1. december 2008
Studieafslutning (Faktiske)
1. april 2009
Datoer for studieregistrering
Først indsendt
24. juli 2006
Først indsendt, der opfyldte QC-kriterier
24. juli 2006
Først opslået (Skøn)
26. juli 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. maj 2013
Sidst verificeret
1. maj 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Ledsygdomme
- Muskuloskeletale sygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Gigt
- Gigt, reumatoid
- Lægemidlers fysiologiske virkninger
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Etanercept
Andre undersøgelses-id-numre
- 20021623
- 16.0023
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .