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Clinical Disease Activity With Long Term Natalizumab Treatment

3. januar 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

277

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussels, Belgien
        • Research Site 1
      • Brussels, Belgien
        • Research Site 2
      • Overpelt, Belgien
        • Research Site
  • Tjekkiet
      • Prague, Tjekkiet
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Participants who have been receiving treatment with natalizumab for ≥24 months.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
Medicin: natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Andre navne:
  • Tysabri
  • BG00002
Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
Medicin: natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Andre navne:
  • Tysabri
  • BG00002

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change over time in the number of participants free of new or enlarging FLAIR lesions
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
Tidsramme: 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]
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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%
Tidsramme: Post long term treatment with natalizumab (>2 years) through Year 4
Post long term treatment with natalizumab (>2 years) through Year 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biogen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. december 2015

Primær færdiggørelse (Faktiske)

18. august 2016

Studieafslutning (Faktiske)

18. august 2016

Datoer for studieregistrering

Først indsendt

3. december 2015

Først indsendt, der opfyldte QC-kriterier

4. februar 2016

Først opslået (Skøn)

9. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. januar 2019

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BEL-TYS-14-10727

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