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

10 maja 2013 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

468

Faza

  • Faza 3

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: 1
Biologiczny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Total Exposure to Etanercept With Gaps
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Up to 8 years
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
Up to 8 years
Death
Ramy czasowe: Up to 8 years
Death of the participant on study up to 30 days after the last dose of etanercept
Up to 8 years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
ACR20 Response at Month 3
Ramy czasowe: 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
Ramy czasowe: Up to 8 years
Duration of etanercept dosing
Up to 8 years
ACR20 Response at Month 12
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amgen

Współpracownicy

Immunex Corporation

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 1998

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2008

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2009

Daty rejestracji na studia

Pierwszy przesłany

24 lipca 2006

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 lipca 2006

Pierwszy wysłany (Oszacować)

26 lipca 2006

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

14 maja 2013

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 maja 2013

Ostatnia weryfikacja

1 maja 2013

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20021623
  • 16.0023

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