Clinical Disease Activity With Long Term Natalizumab Treatment
3 januari 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
277
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Participants who have been receiving treatment with natalizumab for ≥24 months.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
|
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Andere namen:
|
|
Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
|
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change over time in the number of participants free of new or enlarging FLAIR lesions
Tijdsspanne: Treatment years 3 and 4
|
Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
|
Treatment years 3 and 4
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Annualized brain volume change rate as assessed by percent brain volume change [PBVC]
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Cumulative number of new ≥6-month confirmed T1-hypointense lesions
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Annualized T1-hypointense and FLAIR lesion volume change
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Cumulative percent change in T1-hypointense and FLAIR lesion volume
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
|
Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
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
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
Number of total participants and 4-year completers with NEDA as measured by clinical measures
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
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
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
Number of total participants and 4-year completers with NEDA as measured by radiological measures
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
|
Number of participants with brain volume loss ≤0.2% and ≤0.4%
Tijdsspanne: Post long term treatment with natalizumab (>2 years) through Year 4
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 december 2015
Primaire voltooiing (Werkelijk)
18 augustus 2016
Studie voltooiing (Werkelijk)
18 augustus 2016
Studieregistratiedata
Eerst ingediend
3 december 2015
Eerst ingediend dat voldeed aan de QC-criteria
4 februari 2016
Eerst geplaatst (Schatting)
9 februari 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 januari 2019
Laatste update ingediend die voldeed aan QC-criteria
3 januari 2019
Laatst geverifieerd
1 december 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Ziekten van het immuunsysteem
- Demyeliniserende auto-immuunziekten, CZS
- Auto-immuunziekten van het zenuwstelsel
- Demyeliniserende ziekten
- Auto-immuunziekten
- Multiple sclerose
- Multiple sclerose, relapsing-remitting
- Fysiologische effecten van medicijnen
- Immunologische factoren
- Natalizumab
Andere studie-ID-nummers
- BEL-TYS-14-10727
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