Clinical Disease Activity With Long Term Natalizumab Treatment
3. Januar 2019 aktualisiert von: Biogen
MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium.
The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Natalizumab will not be provided to participants by Biogen as a part of this study.
Participants will remain on natalizumab therapy as prescribed by their physician.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
277
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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Brussels, Belgien
- Research Site 1
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Brussels, Belgien
- Research Site 2
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Overpelt, Belgien
- Research Site
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Prague, Tschechien
- Research Site
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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
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Participants who have been receiving treatment with natalizumab for ≥24 months.
Beschreibung
Key Inclusion Criteria:
- Diagnosis of RRMS.
- Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
- ≥1 MRI scan of sufficient quality for reliable measurement.
- Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
- ≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
- EDSS ≤ 6.5.
Key Exclusion Criteria:
- Anti-natalizumab antibody detection.
- Prior treatment with alemtuzumab.
- Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
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Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Andere Namen:
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Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
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Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change over time in the number of participants free of new or enlarging FLAIR lesions
Zeitfenster: Treatment years 3 and 4
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Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
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Treatment years 3 and 4
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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Post long term treatment with natalizumab (>2 years) through Year 4
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Annualized brain volume change rate as assessed by percent brain volume change [PBVC]
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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Post long term treatment with natalizumab (>2 years) through Year 4
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Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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Post long term treatment with natalizumab (>2 years) through Year 4
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Cumulative number of new ≥6-month confirmed T1-hypointense lesions
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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Post long term treatment with natalizumab (>2 years) through Year 4
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Annualized T1-hypointense and FLAIR lesion volume change
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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Post long term treatment with natalizumab (>2 years) through Year 4
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Cumulative percent change in T1-hypointense and FLAIR lesion volume
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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Post long term treatment with natalizumab (>2 years) through Year 4
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Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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No relapse and no ≥6-month confirmed Expanded Disability Status Scale (EDSS) progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
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Post long term treatment with natalizumab (>2 years) through Year 4
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Number of total participants and 4-year completers with NEDA as measured by clinical measures
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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No relapse and no ≥6-month confirmed EDSS progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions, brain volume change rate as assessed by PBVC
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Post long term treatment with natalizumab (>2 years) through Year 4
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Number of total participants and 4-year completers with NEDA as measured by radiological measures
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
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Post long term treatment with natalizumab (>2 years) through Year 4
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Number of participants with brain volume loss ≤0.2% and ≤0.4%
Zeitfenster: Post long term treatment with natalizumab (>2 years) through Year 4
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Post long term treatment with natalizumab (>2 years) through Year 4
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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 (Tatsächlich)
31. Dezember 2015
Primärer Abschluss (Tatsächlich)
18. August 2016
Studienabschluss (Tatsächlich)
18. August 2016
Studienanmeldedaten
Zuerst eingereicht
3. Dezember 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Februar 2016
Zuerst gepostet (Schätzen)
9. Februar 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Januar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Januar 2019
Zuletzt verifiziert
1. Dezember 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Erkrankungen des Immunsystems
- Demyelinisierende Autoimmunerkrankungen, ZNS
- Autoimmunerkrankungen des Nervensystems
- Demyelinisierende Krankheiten
- Autoimmunerkrankungen
- Multiple Sklerose
- Multiple Sklerose, schubförmig remittierend
- Physiologische Wirkungen von Arzneimitteln
- Immunologische Faktoren
- Natalizumab
Andere Studien-ID-Nummern
- BEL-TYS-14-10727
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