- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02775110
Natalizumab Temporary Discontinuation Study (NaTDS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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New York
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Buffalo, New York, Forenede Stater, 14203
- Buffalo Neuroimaging Analysis Center
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Buffalo, New York, Forenede Stater, 14203
- Jacobs Neurological Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Bianca Weinstock-Guttman, MD, Jacob's Neurological Institute
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- USTYS0910017/JNI-2010-31
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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