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- Klinische proef NCT02775110
Natalizumab Temporary Discontinuation Study (NaTDS)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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New York
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Buffalo, New York, Verenigde Staten, 14203
- Buffalo Neuroimaging Analysis Center
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Buffalo, New York, Verenigde Staten, 14203
- Jacobs Neurological Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of recorded infections including viral opportunistic infection
Tijdsspanne: 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
Tijdsspanne: 12 months
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12 months
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Number gadolinium-enhancing lesions
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of clinical relapses
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Bianca Weinstock-Guttman, MD, Jacob's Neurological Institute
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- USTYS0910017/JNI-2010-31
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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