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Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

17 czerwca 2011 zaktualizowane przez: Abbott

A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

88

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Japonia
      • Aichi, Japonia
      • Chiba, Japonia
      • Fukuoka, Japonia
      • Gunma, Japonia
      • Hokkaido, Japonia
      • Hyogo, Japonia
      • Ibaraki, Japonia
      • Kanagawa, Japonia
      • Miyagi, Japonia
      • Nagano, Japonia
      • Okayama, Japonia
      • Osaka, Japonia
      • Saitama, Japonia
      • Shizuoka, Japonia
      • Tokyo, Japonia
      • Toyama, Japonia

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

20 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Completed Week 36 of Study M03-651 [NCT 00235872]
  • Wish to participate in self-injection study
  • Give written informed consent
  • Comply with protocol requirements

Exclusion Criteria:

  • Subject develops serious adverse events at time of eligibility confirmation
  • Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
  • Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
  • The investigator considers the subject inappropriate for participation

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
Eksperymentalny: Adalimumab
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT 00235872]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
Biologiczny: Adalimumab
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
Inne nazwy:
  • ABT-D2E7
  • Humira

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit.
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
Ramy czasowe: Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities [0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so]), a component of the ACR criteria by visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Presence of Morning Stiffness by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Ramy czasowe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Abbott

Współpracownicy

Eisai Co., Ltd.
Abbott Japan Co.,Ltd

Śledczy

  • Dyrektor Studium: Shigeki Hashimoto, PhD, Abbott Japan

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 marca 2006

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2006

Daty rejestracji na studia

Pierwszy przesłany

10 stycznia 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 stycznia 2008

Pierwszy wysłany (Oszacować)

29 stycznia 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

21 czerwca 2011

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 czerwca 2011

Ostatnia weryfikacja

1 czerwca 2011

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • M05-775

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Adalimumab

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Pakistan

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
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