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- Sperimentazione clinica NCT00356590
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
10 maggio 2013 aggiornato da: 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.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
468
Fase
- Fase 3
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
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
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: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Total Exposure to Etanercept With Gaps
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 8 years
|
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
|
Up to 8 years
|
Death
Lasso di tempo: Up to 8 years
|
Death of the participant on study up to 30 days after the last dose of etanercept
|
Up to 8 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
ACR20 Response at Month 3
Lasso di tempo: 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
Lasso di tempo: Up to 8 years
|
Duration of etanercept dosing
|
Up to 8 years
|
ACR20 Response at Month 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
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
- 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.
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
1 dicembre 1998
Completamento primario (Effettivo)
1 dicembre 2008
Completamento dello studio (Effettivo)
1 aprile 2009
Date di iscrizione allo studio
Primo inviato
24 luglio 2006
Primo inviato che soddisfa i criteri di controllo qualità
24 luglio 2006
Primo Inserito (Stima)
26 luglio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
14 maggio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 maggio 2013
Ultimo verificato
1 maggio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie del tessuto connettivo
- Artrite
- Artrite, reumatoide
- Effetti fisiologici delle droghe
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti gastrointestinali
- Etanercept
Altri numeri di identificazione dello studio
- 20021623
- 16.0023
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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