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En studie som evaluerer den virkelige opplevelsen til deltakere behandlet med BRIUMVI® (Ublituximab-xiiy) for residiverende multippel sklerose (RMS) (ENABLE)

28. oktober 2026 oppdatert av: TG Therapeutics, Inc.

Virkelig verdenserfaring med BRIUMVI® (UblituximAB-xiiy)-behandlede pasienter: En longitudinell registreringsstudie (ENABLE)

The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

2000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35209
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Cullman, Alabama, Forente stater, 35058
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Huntsville, Alabama, Forente stater, 35802
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Mobile, Alabama, Forente stater, 36604
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • Gilbert, Arizona, Forente stater, 85297
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Phoenix, Arizona, Forente stater, 85032
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Scottsdale, Arizona, Forente stater, 85253
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • California
      • Fresno, California, Forente stater, 93720
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Newport Beach, California, Forente stater, 92663
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Orange, California, Forente stater, 68130
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • West Hollywood, California, Forente stater, 90048
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Basalt, Colorado, Forente stater, 81621
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Colorado Springs, Colorado, Forente stater, 80918
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Colorado Springs, Colorado, Forente stater, 80920
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Denver, Colorado, Forente stater, 80222
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Fort Collins, Colorado, Forente stater, 80528
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Grand Junction, Colorado, Forente stater, 81501
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Connecticut
      • Farmington, Connecticut, Forente stater, 06032
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Hartford, Connecticut, Forente stater, 06112
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Florida
      • Altamonte Springs, Florida, Forente stater, 32714
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Boca Raton, Florida, Forente stater, 33486
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Clearwater, Florida, Forente stater, 33761
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Gainesville, Florida, Forente stater, 32611
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Maitland, Florida, Forente stater, 32751
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Miami, Florida, Forente stater, 33176
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Naples, Florida, Forente stater, 34105
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Pensacola, Florida, Forente stater, 32504
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Weston, Florida, Forente stater, 33331
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Atlanta, Georgia, Forente stater, 30327
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Savannah, Georgia, Forente stater, 31406
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Smyrna, Georgia, Forente stater, 30080
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96817
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Idaho
      • Coeur d'Alene, Idaho, Forente stater, 83814
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Chicago, Illinois, Forente stater, 60611
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Evanston, Illinois, Forente stater, 60201
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Urbana, Illinois, Forente stater, 61801
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Indiana
      • Avon, Indiana, Forente stater, 46123
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Kansas
      • Roeland Park, Kansas, Forente stater, 66205
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40504
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Louisville, Kentucky, Forente stater, 40202
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Maryland
      • Baltimore, Maryland, Forente stater, 21237
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Glen Burnie, Maryland, Forente stater, 21061
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Burlington, Massachusetts, Forente stater, 01805
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Norfolk, Massachusetts, Forente stater, 02481
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48019
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Detroit, Michigan, Forente stater, 48202
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Farmington, Michigan, Forente stater, 48334
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Owosso, Michigan, Forente stater, 48867
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Rochester Hills, Michigan, Forente stater, 48307
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Minnesota
      • Golden Valley, Minnesota, Forente stater, 55422
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Plymouth, Minnesota, Forente stater, 55446
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Montana
      • Billings, Montana, Forente stater, 59101
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68502
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Omaha, Nebraska, Forente stater, 68154
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • Bridgewater, New Jersey, Forente stater, 08807
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Cherry Hill, New Jersey, Forente stater, 08002
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Freehold, New Jersey, Forente stater, 07728
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Livingston, New Jersey, Forente stater, 07039
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Neptune City, New Jersey, Forente stater, 00753
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Paramus, New Jersey, Forente stater, 07652
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Teaneck, New Jersey, Forente stater, 07666
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • New York
      • Amherst, New York, Forente stater, 14226
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Lake Success, New York, Forente stater, 11042
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • New York, New York, Forente stater, 11501
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • The Bronx, New York, Forente stater, 10467
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28210
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • New Bern, North Carolina, Forente stater, 28562
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Raleigh, North Carolina, Forente stater, 27607
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Ohio
      • Centerville, Ohio, Forente stater, 45429
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Centerville, Ohio, Forente stater, 45459
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Cincinnati, Ohio, Forente stater, 45212
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Cleveland, Ohio, Forente stater, 44195
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Columbus, Ohio, Forente stater, 43214
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Columbus, Ohio, Forente stater, 43235
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Toledo, Ohio, Forente stater, 43608
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Oklahoma
      • Norman, Oklahoma, Forente stater, 73019
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Oregon
      • Portland, Oregon, Forente stater, 97225
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forente stater, 18017
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Franklin, Tennessee, Forente stater, 37067
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Knoxville, Tennessee, Forente stater, 37996
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Mount Juliet, Tennessee, Forente stater, 37122
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Nashville, Tennessee, Forente stater, 37215
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Spring Hill, Tennessee, Forente stater, 37174
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Austin, Texas, Forente stater, 78723
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Austin, Texas, Forente stater, 78712
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Austin, Texas, Forente stater, 78758
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Dallas, Texas, Forente stater, 75206
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Dallas, Texas, Forente stater, 75243
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Edinburg, Texas, Forente stater, 78572
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Frisco, Texas, Forente stater, 75035
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Lubbock, Texas, Forente stater, 79414
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Utah
      • Ogden, Utah, Forente stater, 84403
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Salt Lake City, Utah, Forente stater, 84103
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Salem, Virginia, Forente stater, 24153
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Vienna, Virginia, Forente stater, 22182
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Virginia Beach, Virginia, Forente stater, 23456
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Kirkland, Washington, Forente stater, 98034
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26506
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
    • Wisconsin
      • Greenfield, Wisconsin, Forente stater, 53228
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Neenah, Wisconsin, Forente stater, 54956
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
      • Waukesha, Wisconsin, Forente stater, 53188
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Rekruttering
        • TG Therapeutics Investigational Trial Site
  • Storbritannia
      • London, Storbritannia, SW170QT
        • Rekruttering
        • TG Therapeutics Investigational Trial Site

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).

Beskrivelse

Inclusion Criteria:

  1. Confirmed Multiple Sclerosis (MS) diagnosis.
  2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.

Exclusion Criteria:

  1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.
  2. Any active infection (e.g., active Hepatitis B virus [HBV])
  3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_ONLY
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
BRIUMVI® (Ublituximab-xiiy)

Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.
Annen: No Intervention

No Intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Annualisert tilbakefallsfrekvens (ARR)
Tidsramme: Frem til uke 96
Frem til uke 96

Sekundære resultatmål

Resultatmål
Tidsramme
Prosentandel av deltakere med uønskede hendelser (AE) og alvorlige uønskede hendelser (SAE)
Tidsramme: Frem til uke 96
Frem til uke 96
Antall deltakere med infusjonsrelatert reaksjon (IRR) ved hver infusjon
Tidsramme: Frem til uke 96
Frem til uke 96

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

TG Therapeutics, Inc.

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 (Faktiske)

22. juli 2024

Primær fullføring (Antatt)

1. april 2032

Studiet fullført (Antatt)

1. april 2032

Datoer for studieregistrering

Først innsendt

23. mai 2024

Først innsendt som oppfylte QC-kriteriene

23. mai 2024

Først lagt ut (Faktiske)

30. mai 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TG1101-RMS406

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere