Natalizumab Temporary Discontinuation Study (NaTDS)
13. mai 2016 oppdatert av: Robert Zivadinov, MD, PhD, University at Buffalo
This study evaluates the discontinuation of natalizumab either immediately or tapered off in the treatment of multiple sclerosis.
Half of the fifty (50) participants will discontinue natalizumab immediately and the other half will taper off the drug, having two additional infusions, one at six weeks- and one at eight weeks-post discontinuation.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Natalizumab is a pharmaceutical intervention used in the management of multiple sclerosis.
The decision to discontinue natalizumab therapy is often raised in patients defined as high-risk for PML despite good clinical efficacy. During the therapy cessation period following large phase III trials, a return to the prestudy disease activity was reached by four months post-discontinuation. Shorter therapy was associated with a trend for a more severe disease activity pointing to a possible 'rebound' effect after natalizumab discontinuation.
This study focuses on two different approaches: an immediate versus a step-wise/tapered down natalizumab discontinuation protocol, both with reinstitution of a different disease modifying therapy (DMT) within 1-6 months from the last natalizumab infusion.
Studietype
Intervensjonell
Registrering (Faktiske)
50
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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Buffalo, New York, Forente stater, 14203
- Buffalo Neuroimaging Analysis Center
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Buffalo, New York, Forente stater, 14203
- Jacobs Neurological Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patient with relapsing-remitting or relapsing-progressive (relapsing-remitting with incomplete recovery and secondary progressive with superimposed relapses) MS according to the McDonald criteria who have been on natalizumab therapy for at least 12 months
- Age 18-65
- Have EDSS scores less than or equal to 7.0
- Positive John Cunningham (JC) virus antibody results at screening
- Signed informed consent
- None of the exclusion criteria
Exclusion Criteria:
- Patients not willing or able to personally provide informed consent (subjects with cognitive impairment that effects the ability to provide informed consent for participation)
- Patients with active disease per clinical and MRI evaluation at baseline
- Patients with renal disease that precludes having an MRI with gadolinium contrast
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Immediate Discontinuation Group
Patients will discontinue the natalizumab therapy at once and initiate another disease modifying therapy at 1 month following the last natalizumab infusion.
The disease modifying therapy at 1 month following natalizumab discontinuation will be at the discretion of the neurologist and may differ among patients.
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Patients will be randomized to one of two groups: The Immediate Discontinuation Group (stop natalizumab immediately and continue with new DMT 1 month afterward) and the Taper-off Group (two additional infusions of natalizumab, one at 6 weeks and the next at 8 weeks following discontinuation.
A new DMT will be initiated within 2 months of final natalizumab infusion).
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Eksperimentell: Taper-off Group
Patients will be administered two more natalizumab infusion, one at six weeks and the second at eight weeks (14 weeks from study entry), followed by six months natalizumab discontinuation.
Another DMT will be initiated within two months after the last natalizumab infusion.
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Patients will be randomized to one of two groups: The Immediate Discontinuation Group (stop natalizumab immediately and continue with new DMT 1 month afterward) and the Taper-off Group (two additional infusions of natalizumab, one at 6 weeks and the next at 8 weeks following discontinuation.
A new DMT will be initiated within 2 months of final natalizumab infusion).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of recorded infections including viral opportunistic infection
Tidsramme: Up to 1 year follow-up
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Number of recorded infections including viral opportunistic infections (i.e., shingles) will be recorded up to 1-year follow-up; continuous close vigilance will be maintained for possible cases of progressive multifocal leukoencephalopathy (PML)
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Up to 1 year follow-up
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Saturation percentage of α4β1integrin receptors on the surface of lymphocytes
Tidsramme: 12 months
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12 months
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Number gadolinium-enhancing lesions
Tidsramme: Change between baseline-6 months, 6 months-12 months, and baseline-12 months
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Number of gadolinium-enhancing lesions
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Change between baseline-6 months, 6 months-12 months, and baseline-12 months
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Absolute changes in gadolinium-enhancing and T2-weighted lesion volume between timepoints
Tidsramme: Change between baseline-6 months, 6 months-12 months, and baseline-12 months
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Absolute changes in gadolinium-enhancing and T2-weighted lesion volume
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Change between baseline-6 months, 6 months-12 months, and baseline-12 months
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Sum of new and enlarging T2-weighted lesions
Tidsramme: Change between baseline-6 months, 6 months-12 months, and baseline-12 months
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Sum of new and enlarging lesions as seen on T2-weighted images
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Change between baseline-6 months, 6 months-12 months, and baseline-12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of clinical relapses
Tidsramme: Either baseline (immediate discontinuation group) or 6 months (taper-off group)
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Number of clinical relapses will be assessed at the time of natalizumab therapy discontinuation which will be different between the two groups
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Either baseline (immediate discontinuation group) or 6 months (taper-off group)
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Expanded Disability Status Scale (EDSS) score
Tidsramme: Either baseline (immediate discontinuation group) or 6 months (taper-off group)
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Expanded disability status scale score
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Either baseline (immediate discontinuation group) or 6 months (taper-off group)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Bianca Weinstock-Guttman, MD, Jacob's Neurological Institute
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2012
Primær fullføring (Faktiske)
1. mars 2014
Studiet fullført (Faktiske)
1. mars 2014
Datoer for studieregistrering
Først innsendt
29. desember 2015
Først innsendt som oppfylte QC-kriteriene
13. mai 2016
Først lagt ut (Anslag)
17. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- USTYS0910017/JNI-2010-31
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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