En undersøgelse, der evaluerer den virkelige verdens oplevelse af deltagere behandlet med BRIUMVI® (Ublituximab-xiiy) for recidiverende multipel sklerose (RMS) (ENABLE)
28. oktober 2026 opdateret af: TG Therapeutics, Inc.
Virkelig verdenserfaring med BRIUMVI® (UblituximAB-xiiy) behandlede patienter: En longitudinel registreringsundersøgelse (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
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
2000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: TG Therapeutics Clinical Support Team
- Telefonnummer: 1-877-575-8489
- E-mail: clinicalsupport@tgtxinc.com
Studiesteder
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London, Det Forenede Kongerige, SW170QT
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
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- TG Therapeutics Investigational Trial Site
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Cullman, Alabama, Forenede Stater, 35058
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- TG Therapeutics Investigational Trial Site
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Huntsville, Alabama, Forenede Stater, 35802
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- TG Therapeutics Investigational Trial Site
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Mobile, Alabama, Forenede Stater, 36604
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- TG Therapeutics Investigational Trial Site
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Arizona
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Gilbert, Arizona, Forenede Stater, 85297
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Phoenix, Arizona, Forenede Stater, 85032
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- TG Therapeutics Investigational Trial Site
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Scottsdale, Arizona, Forenede Stater, 85253
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- TG Therapeutics Investigational Trial Site
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California
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Fresno, California, Forenede Stater, 93720
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Newport Beach, California, Forenede Stater, 92663
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- TG Therapeutics Investigational Trial Site
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Orange, California, Forenede Stater, 68130
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- TG Therapeutics Investigational Trial Site
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West Hollywood, California, Forenede Stater, 90048
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Basalt, Colorado, Forenede Stater, 81621
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- TG Therapeutics Investigational Trial Site
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Colorado Springs, Colorado, Forenede Stater, 80918
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- TG Therapeutics Investigational Trial Site
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Colorado Springs, Colorado, Forenede Stater, 80920
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- TG Therapeutics Investigational Trial Site
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Denver, Colorado, Forenede Stater, 80222
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- TG Therapeutics Investigational Trial Site
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Fort Collins, Colorado, Forenede Stater, 80528
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- TG Therapeutics Investigational Trial Site
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Grand Junction, Colorado, Forenede Stater, 81501
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- TG Therapeutics Investigational Trial Site
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06032
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Hartford, Connecticut, Forenede Stater, 06112
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- TG Therapeutics Investigational Trial Site
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Florida
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Altamonte Springs, Florida, Forenede Stater, 32714
- Rekruttering
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Boca Raton, Florida, Forenede Stater, 33486
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Clearwater, Florida, Forenede Stater, 33761
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- TG Therapeutics Investigational Trial Site
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Gainesville, Florida, Forenede Stater, 32611
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Maitland, Florida, Forenede Stater, 32751
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Miami, Florida, Forenede Stater, 33176
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- TG Therapeutics Investigational Trial Site
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Naples, Florida, Forenede Stater, 34105
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Orlando, Florida, Forenede Stater, 32806
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- TG Therapeutics Investigational Trial Site
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Pensacola, Florida, Forenede Stater, 32504
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- TG Therapeutics Investigational Trial Site
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Weston, Florida, Forenede Stater, 33331
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Atlanta, Georgia, Forenede Stater, 30327
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Savannah, Georgia, Forenede Stater, 31406
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- TG Therapeutics Investigational Trial Site
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Smyrna, Georgia, Forenede Stater, 30080
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96817
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Idaho
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Chicago, Illinois, Forenede Stater, 60611
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Evanston, Illinois, Forenede Stater, 60201
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Urbana, Illinois, Forenede Stater, 61801
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Indiana
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Avon, Indiana, Forenede Stater, 46123
- Rekruttering
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Kansas
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Roeland Park, Kansas, Forenede Stater, 66205
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40504
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Louisville, Kentucky, Forenede Stater, 40202
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Maryland
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Baltimore, Maryland, Forenede Stater, 21237
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Glen Burnie, Maryland, Forenede Stater, 21061
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
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Burlington, Massachusetts, Forenede Stater, 01805
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Norfolk, Massachusetts, Forenede Stater, 02481
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48019
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Detroit, Michigan, Forenede Stater, 48202
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Farmington, Michigan, Forenede Stater, 48334
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Owosso, Michigan, Forenede Stater, 48867
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Rochester Hills, Michigan, Forenede Stater, 48307
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Minnesota
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Golden Valley, Minnesota, Forenede Stater, 55422
- Rekruttering
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Plymouth, Minnesota, Forenede Stater, 55446
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- TG Therapeutics Investigational Trial Site
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Montana
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Billings, Montana, Forenede Stater, 59101
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68502
- Rekruttering
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Omaha, Nebraska, Forenede Stater, 68154
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- Rekruttering
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New Jersey
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Bridgewater, New Jersey, Forenede Stater, 08807
- Rekruttering
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Cherry Hill, New Jersey, Forenede Stater, 08002
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Freehold, New Jersey, Forenede Stater, 07728
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Livingston, New Jersey, Forenede Stater, 07039
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Neptune City, New Jersey, Forenede Stater, 00753
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Paramus, New Jersey, Forenede Stater, 07652
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Teaneck, New Jersey, Forenede Stater, 07666
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New York
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Amherst, New York, Forenede Stater, 14226
- Rekruttering
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Lake Success, New York, Forenede Stater, 11042
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New York, New York, Forenede Stater, 11501
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The Bronx, New York, Forenede Stater, 10467
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28210
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New Bern, North Carolina, Forenede Stater, 28562
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Raleigh, North Carolina, Forenede Stater, 27607
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Ohio
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Centerville, Ohio, Forenede Stater, 45429
- Rekruttering
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Centerville, Ohio, Forenede Stater, 45459
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Cincinnati, Ohio, Forenede Stater, 45212
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Cleveland, Ohio, Forenede Stater, 44195
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Columbus, Ohio, Forenede Stater, 43214
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Columbus, Ohio, Forenede Stater, 43235
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Toledo, Ohio, Forenede Stater, 43608
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Oklahoma
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Norman, Oklahoma, Forenede Stater, 73019
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Oregon
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Portland, Oregon, Forenede Stater, 97225
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Rekruttering
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Tennessee
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Franklin, Tennessee, Forenede Stater, 37067
- Rekruttering
- TG Therapeutics Investigational Trial Site
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Knoxville, Tennessee, Forenede Stater, 37996
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Mount Juliet, Tennessee, Forenede Stater, 37122
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Nashville, Tennessee, Forenede Stater, 37215
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Spring Hill, Tennessee, Forenede Stater, 37174
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Texas
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Austin, Texas, Forenede Stater, 78723
- Rekruttering
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Austin, Texas, Forenede Stater, 78712
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Austin, Texas, Forenede Stater, 78758
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Dallas, Texas, Forenede Stater, 75206
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Dallas, Texas, Forenede Stater, 75243
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Edinburg, Texas, Forenede Stater, 78572
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- TG Therapeutics Investigational Trial Site
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Frisco, Texas, Forenede Stater, 75035
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Lubbock, Texas, Forenede Stater, 79414
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San Antonio, Texas, Forenede Stater, 78229
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Utah
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Ogden, Utah, Forenede Stater, 84403
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Salt Lake City, Utah, Forenede Stater, 84103
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
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Salem, Virginia, Forenede Stater, 24153
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Vienna, Virginia, Forenede Stater, 22182
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Virginia Beach, Virginia, Forenede Stater, 23456
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Washington
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Kirkland, Washington, Forenede Stater, 98034
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506
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Wisconsin
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Greenfield, Wisconsin, Forenede Stater, 53228
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- TG Therapeutics Investigational Trial Site
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Milwaukee, Wisconsin, Forenede Stater, 53226
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- TG Therapeutics Investigational Trial Site
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Neenah, Wisconsin, Forenede Stater, 54956
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- TG Therapeutics Investigational Trial Site
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Waukesha, Wisconsin, Forenede Stater, 53188
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Guaynabo, Puerto Rico, 00968
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).
Beskrivelse
Inclusion Criteria:
- Confirmed Multiple Sclerosis (MS) diagnosis.
- 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:
- 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.
- Any active infection (e.g., active Hepatitis B virus [HBV])
- 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
BRIUMVI® (Ublituximab-xiiy)
Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS. |
No Intervention |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Annualiseret tilbagefaldsrate (ARR)
Tidsramme: Op til uge 96
|
Op til uge 96
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Procentdel af deltagere med uønskede hændelser (AE'er) og alvorlige bivirkninger (SAE'er)
Tidsramme: Op til uge 96
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Op til uge 96
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Antal deltagere med infusionsrelateret reaktion (IRR) ved hver infusion
Tidsramme: Op til uge 96
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Op til uge 96
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
22. juli 2024
Primær færdiggørelse (Anslået)
1. april 2032
Studieafslutning (Anslået)
1. april 2032
Datoer for studieregistrering
Først indsendt
23. maj 2024
Først indsendt, der opfyldte QC-kriterier
23. maj 2024
Først opslået (Faktiske)
30. maj 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TG1101-RMS406
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .