- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00603993
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
17. Juni 2011 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
88
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Aichi, Japan
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Chiba, Japan
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Fukuoka, Japan
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Gunma, Japan
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Hokkaido, Japan
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Hyogo, Japan
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Ibaraki, Japan
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Kanagawa, Japan
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Miyagi, Japan
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Nagano, Japan
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Okayama, Japan
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Osaka, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tokyo, Japan
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Toyama, Japan
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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
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40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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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.
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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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
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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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
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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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
Zeitfenster: Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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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
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Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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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
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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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
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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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
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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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
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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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
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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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
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Presence of Morning Stiffness by Visit
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Duration (Minutes) of the Presence of Morning Stiffness by Visit
Zeitfenster: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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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.
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Shigeki Hashimoto, PhD, Abbott Japan
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2006
Primärer Abschluss (Tatsächlich)
1. November 2006
Studienanmeldedaten
Zuerst eingereicht
10. Januar 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Januar 2008
Zuerst gepostet (Schätzen)
29. Januar 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
21. Juni 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Juni 2011
Zuletzt verifiziert
1. Juni 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- M05-775
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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