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JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab (STRATIFY-2)

27. september 2016 opdateret af: Biogen

JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

The primary objective of this study is to demonstrate that the incidence of progressive multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in participants who have detectable antibodies to JCV (antibody positive).

The secondary objectives of this study are to: Estimate the incidence of PML in natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody positive, based on a meta-analysis of data obtained from this study and other data sources; Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program; Determine changes in anti-JCV antibody status over time.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

No treatment is provided in this observational, longitudinal cohort study. Study population will consist of United States (US) participants with relapsing MS receiving commercial natalizumab. There are no study-mandated visits. Serum samples will be collected during routine patient care or follow-up visits and will be sent to a central laboratory for analysis (presence of anti-JCV antibody), and remaining serum aliquots will be stored for future natalizumab and PML research. Additional samples will be collected at participating sites from participants who qualify and consent to participate in focused sampling group (participants who are anti-JCV antibody positive at any time point AND have received ≥12 infusions of natalizumab, whether or not they have a history of immunosuppressant use). These samples will be stored for future natalizumab and PML research.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

35895

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • Research Site
      • Birmingham, Alabama, Forenede Stater, 35233
        • Research Site
      • Cullman, Alabama, Forenede Stater, 35058
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      • Tucaloosa, Alabama, Forenede Stater, 35406
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    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
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    • Arizona
      • Flagstaff, Arizona, Forenede Stater, 86001
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      • Gilbert, Arizona, Forenede Stater, 85234
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      • Phoenix, Arizona, Forenede Stater, 85004
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      • Phoenix, Arizona, Forenede Stater, 85018
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      • Phoenix, Arizona, Forenede Stater, 85032
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      • Phoenix, Arizona, Forenede Stater, 85013
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      • Scottsdale, Arizona, Forenede Stater, 85258
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      • Tucson, Arizona, Forenede Stater, 85741
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      • Tucson, Arizona, Forenede Stater, 85718
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    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72703
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      • Little Rock, Arkansas, Forenede Stater, 72205
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      • Sherwood, Arkansas, Forenede Stater, 72120
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    • California
      • Auburn, California, Forenede Stater, 95602
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      • Berkeley, California, Forenede Stater, 94705
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      • Carmel, California, Forenede Stater, 93923
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      • Carmichael, California, Forenede Stater, 95608
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      • Fountain Valley, California, Forenede Stater, 92708
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      • Fresno, California, Forenede Stater, 93720
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      • Fresno, California, Forenede Stater, 93701
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      • Fullerton, California, Forenede Stater, 92835
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      • La Jolla, California, Forenede Stater, 92037
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      • Loma Linda, California, Forenede Stater, 92354
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      • Los Alamitos, California, Forenede Stater, 90720
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      • Los Angeles, California, Forenede Stater, 90073
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      • Los Angeles, California, Forenede Stater, 90033
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      • Marina Del Rey, California, Forenede Stater, 90292
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      • Modesto, California, Forenede Stater, 95355
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      • Newport Beach, California, Forenede Stater, 92663
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      • Northridge, California, Forenede Stater, 91328
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      • Palo Alto, California, Forenede Stater, 94301
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      • Pasadena, California, Forenede Stater, 91105
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      • Pasadena, California, Forenede Stater, 91101
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      • Redding, California, Forenede Stater, 96001
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      • Sacramento, California, Forenede Stater, 95816
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      • San Diego, California, Forenede Stater, 82117
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      • San Francisco, California, Forenede Stater, 94115
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      • San Francisco, California, Forenede Stater, 94117
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      • San Francisco, California, Forenede Stater, 94109
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      • Santa Barbara, California, Forenede Stater, 93105
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      • St. Helena, California, Forenede Stater, 94574
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      • Stanford, California, Forenede Stater, 94305
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      • Stockton, California, Forenede Stater, 95204
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      • Thousand Oaks, California, Forenede Stater, 91360
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      • Tracy, California, Forenede Stater, 95376
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    • Colorado
      • Arvada, Colorado, Forenede Stater, 80002
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      • Aurora, Colorado, Forenede Stater, 80045
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      • Basalt, Colorado, Forenede Stater, 81621
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      • Centennial, Colorado, Forenede Stater, 80112
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      • Colorado Springs, Colorado, Forenede Stater, 80907
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      • Colorado Springs, Colorado, Forenede Stater, 80920
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      • Denver, Colorado, Forenede Stater, 80205
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      • Fort Collins, Colorado, Forenede Stater, 80528
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      • Fort Collins, Colorado, Forenede Stater, 80525
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      • Greeley, Colorado, Forenede Stater, 80631
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      • Parker, Colorado, Forenede Stater, 80138
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      • Pueblo, Colorado, Forenede Stater, 81004
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    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
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      • Derby, Connecticut, Forenede Stater, 06418
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      • Fairfield, Connecticut, Forenede Stater, 06824
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      • Hartford, Connecticut, Forenede Stater, 06105
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      • Hartford, Connecticut, Forenede Stater, 06112
        • Research Site
      • New Haven, Connecticut, Forenede Stater, 06510
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      • New London, Connecticut, Forenede Stater, 06320
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      • Norwich, Connecticut, Forenede Stater, 06360
        • Research Site
    • Delaware
      • Dover, Delaware, Forenede Stater, 19901
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      • Newark, Delaware, Forenede Stater, 19713
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
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      • Washington, District of Columbia, Forenede Stater, 20037
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    • Florida
      • Bradenton, Florida, Forenede Stater, 34205
        • Research Site
      • Clearwater, Florida, Forenede Stater, 33756
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      • Fort Lauderdale, Florida, Forenede Stater, 33308
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      • Fort Walton Beach, Florida, Forenede Stater, 32547
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      • Gainesville, Florida, Forenede Stater, 32607
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      • Hollywood, Florida, Forenede Stater, 33021
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      • Jacksonville, Florida, Forenede Stater, 32209
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      • Jacksonville Beach, Florida, Forenede Stater, 32250
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      • Lighthouse Point, Florida, Forenede Stater, 33064
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      • Maitland, Florida, Forenede Stater, 32751
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      • Melbourne, Florida, Forenede Stater, 32901
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      • Miami, Florida, Forenede Stater, 33136
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      • Miami, Florida, Forenede Stater, 33133
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      • Naples, Florida, Forenede Stater, 34102
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      • Ocala, Florida, Forenede Stater, 34471
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      • Orange Park, Florida, Forenede Stater, 32073
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      • Orlando, Florida, Forenede Stater, 32806
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      • Ormond Beach, Florida, Forenede Stater, 32174
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      • Palm Bay, Florida, Forenede Stater, 32905
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      • Palm Beach Gardens, Florida, Forenede Stater, 33410
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      • Pompano Beach, Florida, Forenede Stater, 33060
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      • Ponte Vedra Beach, Florida, Forenede Stater, 32082
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      • Port Charlotte, Florida, Forenede Stater, 33952
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      • Sarasota, Florida, Forenede Stater, 34239
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      • Sarasota, Florida, Forenede Stater, 34243
        • Research Site
      • St. Petersburg, Florida, Forenede Stater, 33705
        • Research Site
      • St. Petersburg, Florida, Forenede Stater, 33713
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      • Sunrise, Florida, Forenede Stater, 33351
        • Research Site
      • Tallahassee, Florida, Forenede Stater, 32308
        • Research Site
      • Tampa, Florida, Forenede Stater, 33612
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      • Tampa, Florida, Forenede Stater, 33609
        • Research Site
      • Vero Beach, Florida, Forenede Stater, 32960
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      • Winter Haven, Florida, Forenede Stater, 33880
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      • Winter Park, Florida, Forenede Stater, 32792
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    • Georgia
      • Athens, Georgia, Forenede Stater, 30606
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      • Atlanta, Georgia, Forenede Stater, 30309
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      • Atlanta, Georgia, Forenede Stater, 30322
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      • Atlanta, Georgia, Forenede Stater, 30327
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      • Atlanta, Georgia, Forenede Stater, 30312
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      • Columbus, Georgia, Forenede Stater, 31909
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      • Johns Creek, Georgia, Forenede Stater, 30097
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      • Macon, Georgia, Forenede Stater, 31210
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      • Savannah, Georgia, Forenede Stater, 31406
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      • Snellville, Georgia, Forenede Stater, 30078
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Research Site
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Research Site
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Research Site
      • Meridian, Idaho, Forenede Stater, 83642
        • Research Site
      • Nampa, Idaho, Forenede Stater, 83687
        • Research Site
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61701
        • Research Site
      • Bloomington, Illinois, Forenede Stater, 61704
        • Research Site
      • Champaign, Illinois, Forenede Stater, 61820
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60612
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60637
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60611
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60616
        • Research Site
      • Elk Grove Village, Illinois, Forenede Stater, 60007
        • Research Site
      • Elmhurst, Illinois, Forenede Stater, 60126
        • Research Site
      • Evanston, Illinois, Forenede Stater, 60201
        • Research Site
      • Flossmoor, Illinois, Forenede Stater, 60422
        • Research Site
      • Herrin, Illinois, Forenede Stater, 62948
        • Research Site
      • Lake Barrington, Illinois, Forenede Stater, 60010
        • Research Site
      • Lombard, Illinois, Forenede Stater, 60148
        • Research Site
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Research Site
      • Niles, Illinois, Forenede Stater, 60714
        • Research Site
      • North Aurora, Illinois, Forenede Stater, 60542
        • Research Site
      • Palos Heights, Illinois, Forenede Stater, 60463
        • Research Site
      • Peoria, Illinois, Forenede Stater, 61606
        • Research Site
      • St. Charles, Illinois, Forenede Stater, 60175
        • Research Site
    • Indiana
      • Anderson, Indiana, Forenede Stater, 46016
        • Research Site
      • Bloomington, Indiana, Forenede Stater, 47403
        • Research Site
      • Elkhart, Indiana, Forenede Stater, 46514
        • Research Site
      • Evansville, Indiana, Forenede Stater, 47715
        • Research Site
      • Fort Wayne, Indiana, Forenede Stater, 76845
        • Research Site
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Research Site
      • Indianapolis, Indiana, Forenede Stater, 46256
        • Research Site
      • Lafayette, Indiana, Forenede Stater, 47905
        • Research Site
      • Merrillville, Indiana, Forenede Stater, 46410
        • Research Site
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Research Site
      • Valparaiso, Indiana, Forenede Stater, 46383
        • Research Site
    • Iowa
      • Ames, Iowa, Forenede Stater, 80010
        • Research Site
      • Des Moines, Iowa, Forenede Stater, 50314
        • Research Site
      • Des Moines, Iowa, Forenede Stater, 50309
        • Research Site
      • Iowa City, Iowa, Forenede Stater, 52242
        • Research Site
      • West Burlington, Iowa, Forenede Stater, 52655
        • Research Site
    • Kansas
      • Hays, Kansas, Forenede Stater, 67601
        • Research Site
      • Kansas City, Kansas, Forenede Stater, 66160
        • Research Site
      • Lenexa, Kansas, Forenede Stater, 66214
        • Research Site
      • Overland Park, Kansas, Forenede Stater, 66212
        • Research Site
      • Topeka, Kansas, Forenede Stater, 66606
        • Research Site
      • Wichita, Kansas, Forenede Stater, 67214
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      • Wichita, Kansas, Forenede Stater, 67206
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      • Wichita, Kansas, Forenede Stater, 67208
        • Research Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Research Site
      • Lexington, Kentucky, Forenede Stater, 40513
        • Research Site
      • Louisville, Kentucky, Forenede Stater, 40207
        • Research Site
      • Paducah, Kentucky, Forenede Stater, 42003
        • Research Site
    • Louisiana
      • Alexandria, Louisiana, Forenede Stater, 71301
        • Research Site
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Research Site
      • Baton Rouge, Louisiana, Forenede Stater, 70810
        • Research Site
      • Lacombe, Louisiana, Forenede Stater, 70445
        • Research Site
      • Lafayette, Louisiana, Forenede Stater, 70506
        • Research Site
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Research Site
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Research Site
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Research Site
    • Maine
      • Belfast, Maine, Forenede Stater, 04915
        • Research Site
      • Lewiston, Maine, Forenede Stater, 04240
        • Research Site
      • Scarborough, Maine, Forenede Stater, 04074
        • Research Site
      • Westbrook, Maine, Forenede Stater, 04092
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    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Research Site
      • Baltimore, Maryland, Forenede Stater, 21201
        • Research Site
      • Baltimore, Maryland, Forenede Stater, 21287
        • Research Site
      • Bethesda, Maryland, Forenede Stater, 20814
        • Research Site
      • Frederick, Maryland, Forenede Stater, 21702
        • Research Site
      • Hagerstown, Maryland, Forenede Stater, 21742
        • Research Site
    • Massachusetts
      • Attleboro, Massachusetts, Forenede Stater, 02703
        • Research Site
      • Boston, Massachusetts, Forenede Stater, 02111
        • Research Site
      • Boston, Massachusetts, Forenede Stater, 02215
        • Research Site
      • Boston, Massachusetts, Forenede Stater, 02135
        • Research Site
      • Brookline, Massachusetts, Forenede Stater, 02445
        • Research Site
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Research Site
      • Milford, Massachusetts, Forenede Stater, 01757
        • Research Site
      • Peabody, Massachusetts, Forenede Stater, 01960
        • Research Site
      • Springfield, Massachusetts, Forenede Stater, 01104
        • Research Site
      • Worcester, Massachusetts, Forenede Stater, 01605
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Research Site
      • Bingham Farms, Michigan, Forenede Stater, 48025
        • Research Site
      • Cinton Township, Michigan, Forenede Stater, 48035
        • Research Site
      • Detroit, Michigan, Forenede Stater, 48202
        • Research Site
      • Detroit, Michigan, Forenede Stater, 48201
        • Research Site
      • East Lansing, Michigan, Forenede Stater, 48824
        • Research Site
      • Farmington Hills, Michigan, Forenede Stater, 48334
        • Research Site
      • Grand Rapids, Michigan, Forenede Stater, 49525
        • Research Site
      • Kalamazoo, Michigan, Forenede Stater, 49048
        • Research Site
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Research Site
      • Midland, Michigan, Forenede Stater, 48640
        • Research Site
      • Muskegon, Michigan, Forenede Stater, 49444
        • Research Site
      • Rochester Hills, Michigan, Forenede Stater, 48307
        • Research Site
      • Roseville, Michigan, Forenede Stater, 48066
        • Research Site
      • Saginaw, Michigan, Forenede Stater, 48604
        • Research Site
      • Southfield, Michigan, Forenede Stater, 48034
        • Research Site
      • Traverse City, Michigan, Forenede Stater, 49684
        • Research Site
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Research Site
      • Woodhaven, Michigan, Forenede Stater, 48183
        • Research Site
    • Minnesota
      • Golden Valley, Minnesota, Forenede Stater, 55422
        • Research Site
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Research Site
      • Minneapolis, Minnesota, Forenede Stater, 55414
        • Research Site
      • Rochester, Minnesota, Forenede Stater, 55905
        • Research Site
    • Mississippi
      • Greenwood, Mississippi, Forenede Stater, 38930
        • Research Site
      • Hattiesburg, Mississippi, Forenede Stater, 39401
        • Research Site
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Research Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Research Site
      • Nixa, Missouri, Forenede Stater, 65714
        • Research Site
      • Springfield, Missouri, Forenede Stater, 65807
        • Research Site
      • St. Louis, Missouri, Forenede Stater, 63141
        • Research Site
      • St. Louis, Missouri, Forenede Stater, 63110
        • Research Site
      • St. Louis, Missouri, Forenede Stater, 63104
        • Research Site
      • St. Louis, Missouri, Forenede Stater, 63131
        • Research Site
      • Washington, Missouri, Forenede Stater, 63090
        • Research Site
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Research Site
      • Great Falls, Montana, Forenede Stater, 59405
        • Research Site
      • Missoula, Montana, Forenede Stater, 59802
        • Research Site
    • Nebraska
      • Hastings, Nebraska, Forenede Stater, 68901
        • Research Site
      • Lincoln, Nebraska, Forenede Stater, 68521
        • Research Site
      • Norfolk, Nebraska, Forenede Stater, 68701
        • Research Site
      • North Platte, Nebraska, Forenede Stater, 69101
        • Research Site
      • Omaha, Nebraska, Forenede Stater, 68198
        • Research Site
      • Omaha, Nebraska, Forenede Stater, 68131
        • Research Site
      • Scottsbluff, Nebraska, Forenede Stater, 69361
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Research Site
      • Reno, Nevada, Forenede Stater, 89502
        • Research Site
      • Reno, Nevada, Forenede Stater, 89509
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03766
        • Research Site
    • New Jersey
      • Bayonne, New Jersey, Forenede Stater, 07002
        • Research Site
      • Denville, New Jersey, Forenede Stater, 07834
        • Research Site
      • Edison, New Jersey, Forenede Stater, 08820
        • Research Site
      • Flemington, New Jersey, Forenede Stater, 08822
        • Research Site
      • Freehold, New Jersey, Forenede Stater, 07728
        • Research Site
      • Lawrenceville, New Jersey, Forenede Stater, 08648
        • Research Site
      • Livingston, New Jersey, Forenede Stater, 07039
        • Research Site
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Research Site
      • Newark, New Jersey, Forenede Stater, 07103
        • Research Site
      • Paterson, New Jersey, Forenede Stater, 07503
        • Research Site
      • Stratford, New Jersey, Forenede Stater, 08084
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      • Teaneck, New Jersey, Forenede Stater, 07666
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      • West Long Branch, New Jersey, Forenede Stater, 07764
        • Research Site
    • New Mexico
      • Alburquerque, New Mexico, Forenede Stater, 87106
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    • New York
      • Albany, New York, Forenede Stater, 12206
        • Research Site
      • Albany, New York, Forenede Stater, 12208
        • Research Site
      • Albany, New York, Forenede Stater, 12205
        • Research Site
      • Amherst, New York, Forenede Stater, 14226
        • Research Site
      • Bay Shore, New York, Forenede Stater, 11706
        • Research Site
      • Brooklyn, New York, Forenede Stater, 11220
        • Research Site
      • Brooklyn, New York, Forenede Stater, 11219
        • Research Site
      • Brooklyn, New York, Forenede Stater, 11215
        • Research Site
      • Buffalo, New York, Forenede Stater, 14203
        • Research Site
      • Camillus, New York, Forenede Stater, 13031
        • Research Site
      • Cedarhurst, New York, Forenede Stater, 11516
        • Research Site
      • Corning, New York, Forenede Stater, 14830
        • Research Site
      • East Meadow, New York, Forenede Stater, 11554
        • Research Site
      • East Syracuse, New York, Forenede Stater, 13057
        • Research Site
      • Flushing, New York, Forenede Stater, 11365
        • Research Site
      • Fresh Meadows, New York, Forenede Stater, 11365
        • Research Site
      • Great Neck, New York, Forenede Stater, 11021
        • Research Site
      • Kingston, New York, Forenede Stater, 12401
        • Research Site
      • Lake Success, New York, Forenede Stater, 11042
        • Research Site
      • Latham, New York, Forenede Stater, 12110
        • Research Site
      • Mineola, New York, Forenede Stater, 11501
        • Research Site
      • Mount Kisco, New York, Forenede Stater, 10549
        • Research Site
      • New Hyde Park, New York, Forenede Stater, 11040
        • Research Site
      • New York, New York, Forenede Stater, 10016
        • Research Site
      • New York, New York, Forenede Stater, 10065
        • Research Site
      • New York, New York, Forenede Stater, 10022
        • Research Site
      • New York, New York, Forenede Stater, 10029
        • Research Site
      • New York, New York, Forenede Stater, 10019
        • Research Site
      • Newark, New York, Forenede Stater, 14513
        • Research Site
      • Patchogue, New York, Forenede Stater, 11772
        • Research Site
      • Plainview, New York, Forenede Stater, 11803
        • Research Site
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Research Site
      • Rochester, New York, Forenede Stater, 14642
        • Research Site
      • Rochester, New York, Forenede Stater, 14623
        • Research Site
      • Rochester, New York, Forenede Stater, 14608
        • Research Site
      • Rochester, New York, Forenede Stater, 14626
        • Research Site
      • Rye Brook, New York, Forenede Stater, 10573
        • Research Site
      • Schenectady, New York, Forenede Stater, 12308
        • Research Site
      • Staten Island, New York, Forenede Stater, 10306
        • Research Site
      • Stony Brook, New York, Forenede Stater, 11794
        • Research Site
      • Syracuse, New York, Forenede Stater, 13210
        • Research Site
      • West Seneca, New York, Forenede Stater, 14224
        • Research Site
      • White Plains, New York, Forenede Stater, 10604
        • Research Site
      • Williamsville, New York, Forenede Stater, 14221
        • Research Site
      • Woodmere, New York, Forenede Stater, 11598
        • Research Site
    • North Carolina
      • Advance, North Carolina, Forenede Stater, 27006
        • Research Site
      • Asheville, North Carolina, Forenede Stater, 28806
        • Research Site
      • Boone, North Carolina, Forenede Stater, 28607
        • Research Site
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Research Site
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Research Site
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Research Site
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Research Site
      • Concord, North Carolina, Forenede Stater, 28025
        • Research Site
      • Durham, North Carolina, Forenede Stater, 37710
        • Research Site
      • Greensboro, North Carolina, Forenede Stater, 27405
        • Research Site
      • Greenville, North Carolina, Forenede Stater, 27834
        • Research Site
      • Henderson, North Carolina, Forenede Stater, 27536
        • Research Site
      • Hendersonville, North Carolina, Forenede Stater, 28792
        • Research Site
      • High Point, North Carolina, Forenede Stater, 27262
        • Research Site
      • Mooresville, North Carolina, Forenede Stater, 28117
        • Research Site
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Research Site
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Research Site
      • Salisbury, North Carolina, Forenede Stater, 28144
        • Research Site
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Research Site
      • Winston Salem, North Carolina, Forenede Stater, 27103
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Research Site
      • Fargo, North Dakota, Forenede Stater, 58103
        • Research Site
      • Grand Forks, North Dakota, Forenede Stater, 58201
        • Research Site
    • Ohio
      • Akron, Ohio, Forenede Stater, 44320
        • Research Site
      • Bellevue, Ohio, Forenede Stater, 44811
        • Research Site
      • Canton, Ohio, Forenede Stater, 44718
        • Research Site
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Research Site
      • Cleveland, Ohio, Forenede Stater, 44195
        • Research Site
      • Cleveland, Ohio, Forenede Stater, 44119
        • Research Site
      • Columbus, Ohio, Forenede Stater, 43210
        • Research Site
      • Columbus, Ohio, Forenede Stater, 43221
        • Research Site
      • Dayton, Ohio, Forenede Stater, 45417
        • Research Site
      • Franklin, Ohio, Forenede Stater, 45005
        • Research Site
      • Gahanna, Ohio, Forenede Stater, 43230
        • Research Site
      • Newark, Ohio, Forenede Stater, 43055
        • Research Site
      • Toledo, Ohio, Forenede Stater, 43617
        • Research Site
      • Toledo, Ohio, Forenede Stater, 43623
        • Research Site
      • Uniontown, Ohio, Forenede Stater, 44685
        • Research Site
      • Youngstown, Ohio, Forenede Stater, 44504
        • Research Site
      • Zanesville, Ohio, Forenede Stater, 43701
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Research Site
      • Tulsa, Oklahoma, Forenede Stater, 74137
        • Research Site
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Research Site
      • Clackamas, Oregon, Forenede Stater, 97015
        • Research Site
      • Corvallis, Oregon, Forenede Stater, 97330
        • Research Site
      • Medford, Oregon, Forenede Stater, 97504
        • Research Site
      • Portland, Oregon, Forenede Stater, 97239
        • Research Site
      • Portland, Oregon, Forenede Stater, 97225
        • Research Site
      • Roseburg, Oregon, Forenede Stater, 97471
        • Research Site
      • Tulatin, Oregon, Forenede Stater, 97034
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Research Site
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Research Site
      • Allentown, Pennsylvania, Forenede Stater, 18104
        • Research Site
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Research Site
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • Research Site
      • Brackenridge, Pennsylvania, Forenede Stater, 15014
        • Research Site
      • Collegeville, Pennsylvania, Forenede Stater, 19426
        • Research Site
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Research Site
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Research Site
      • Erie, Pennsylvania, Forenede Stater, 16507
        • Research Site
      • Greensburg, Pennsylvania, Forenede Stater, 15601
        • Research Site
      • Harrisburg, Pennsylvania, Forenede Stater, 17111
        • Research Site
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Research Site
      • Johnstown, Pennsylvania, Forenede Stater, 15904
        • Research Site
      • Lititz, Pennsylvania, Forenede Stater, 17543
        • Research Site
      • Meadowbrook, Pennsylvania, Forenede Stater, 19046
        • Research Site
      • Monaca, Pennsylvania, Forenede Stater, 15061
        • Research Site
      • Monroeville, Pennsylvania, Forenede Stater, 15146
        • Research Site
      • Paoli, Pennsylvania, Forenede Stater, 19301
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19124
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
        • Research Site
      • Sellersville, Pennsylvania, Forenede Stater, 18960
        • Research Site
      • Tarentum, Pennsylvania, Forenede Stater, 15084
        • Research Site
      • Upland, Pennsylvania, Forenede Stater, 19013
        • Research Site
      • Washington, Pennsylvania, Forenede Stater, 15301
        • Research Site
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Research Site
      • York, Pennsylvania, Forenede Stater, 17402
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Research Site
      • Providence, Rhode Island, Forenede Stater, 02903
        • Research Site
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Research Site
      • Greenville, South Carolina, Forenede Stater, 29605
        • Research Site
      • Mount Pleasant, South Carolina, Forenede Stater, 29464
        • Research Site
      • Port Royal, South Carolina, Forenede Stater, 29935
        • Research Site
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Research Site
      • Spartanburg, South Carolina, Forenede Stater, 29302
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Research Site
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Research Site
    • Tennessee
      • Bartlett, Tennessee, Forenede Stater, 38134
        • Research Site
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Research Site
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Research Site
      • Columbia, Tennessee, Forenede Stater, 38401
        • Research Site
      • Franklin, Tennessee, Forenede Stater, 37064
        • Research Site
      • Knoxville, Tennessee, Forenede Stater, 37934
        • Research Site
      • Knoxville, Tennessee, Forenede Stater, 37923
        • Research Site
      • Nashville, Tennessee, Forenede Stater, 37205
        • Research Site
      • Nashville, Tennessee, Forenede Stater, 73215
        • Research Site
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Research Site
      • Arlington, Texas, Forenede Stater, 76012
        • Research Site
      • Austin, Texas, Forenede Stater, 78705
        • Research Site
      • Bedford, Texas, Forenede Stater, 76021
        • Research Site
      • Colleyville, Texas, Forenede Stater, 76034
        • Research Site
      • Dallas, Texas, Forenede Stater, 75390
        • Research Site
      • Dallas, Texas, Forenede Stater, 75214
        • Research Site
      • Dallas, Texas, Forenede Stater, 75243
        • Research Site
      • Houston, Texas, Forenede Stater, 77030
        • Research Site
      • Houston, Texas, Forenede Stater, 77024
        • Research Site
      • Kerrville, Texas, Forenede Stater, 78028
        • Research Site
      • Mansfield, Texas, Forenede Stater, 76063
        • Research Site
      • Round Rock, Texas, Forenede Stater, 78681
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78258
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78231
        • Research Site
      • Wichita Falls, Texas, Forenede Stater, 79301
        • Research Site
    • Utah
      • Ivins, Utah, Forenede Stater, 84738
        • Research Site
      • Provo, Utah, Forenede Stater, 84604
        • Research Site
      • Salt Lake City, Utah, Forenede Stater, 84103
        • Research Site
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Research Site
      • Salt Lake City, Utah, Forenede Stater, 84108
        • Research Site
      • Washington Terrace, Utah, Forenede Stater, 84405
        • Research Site
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Research Site
    • Virginia
      • Alexandria, Virginia, Forenede Stater, 22304
        • Research Site
      • Alexandria, Virginia, Forenede Stater, 22310
        • Research Site
      • Carrollton, Virginia, Forenede Stater, 23314
        • Research Site
      • Centreville, Virginia, Forenede Stater, 20120
        • Research Site
      • Charlottesville, Virginia, Forenede Stater, 22903
        • Research Site
      • Christiansburg, Virginia, Forenede Stater, 24073
        • Research Site
      • Fairfax, Virginia, Forenede Stater, 22031
        • Research Site
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Research Site
      • McLean, Virginia, Forenede Stater, 22101
        • Research Site
      • Newport News, Virginia, Forenede Stater, 23601
        • Research Site
      • Norfolk, Virginia, Forenede Stater, 23502
        • Research Site
      • Norfolk, Virginia, Forenede Stater, 23507
        • Research Site
      • Richmond, Virginia, Forenede Stater, 23226
        • Research Site
      • Roanoke, Virginia, Forenede Stater, 24018
        • Research Site
      • Stafford, Virginia, Forenede Stater, 22556
        • Research Site
      • Vienna, Virginia, Forenede Stater, 22182
        • Research Site
      • Winchester, Virginia, Forenede Stater, 22601
        • Research Site
    • Washington
      • Auburn, Washington, Forenede Stater, 98001
        • Research Site
      • Bellingham, Washington, Forenede Stater, 98225
        • Research Site
      • Burien, Washington, Forenede Stater, 98166
        • Research Site
      • Federal Way, Washington, Forenede Stater, 98003
        • Research Site
      • Kirkland, Washington, Forenede Stater, 98034
        • Research Site
      • Mount Vernon, Washington, Forenede Stater, 98274
        • Research Site
      • Renton, Washington, Forenede Stater, 98055
        • Research Site
      • Richland, Washington, Forenede Stater, 99352
        • Research Site
      • Seattle, Washington, Forenede Stater, 98122
        • Research Site
      • Seattle, Washington, Forenede Stater, 98101
        • Research Site
      • Seattle, Washington, Forenede Stater, 98195
        • Research Site
      • Silverdale, Washington, Forenede Stater, 98383
        • Research Site
      • Spokane, Washington, Forenede Stater, 99204
        • Research Site
      • Spokane, Washington, Forenede Stater, 99208
        • Research Site
      • Spokane, Washington, Forenede Stater, 99202
        • Research Site
      • Tacoma, Washington, Forenede Stater, 98405
        • Research Site
      • Wenatchee, Washington, Forenede Stater, 98801
        • Research Site
    • West Virginia
      • Huntington, West Virginia, Forenede Stater, 25702
        • Research Site
      • Point Pleasant, West Virginia, Forenede Stater, 25550
        • Research Site
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Research Site
      • Green Bay, Wisconsin, Forenede Stater, 54308
        • Research Site
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Research Site
      • Madison, Wisconsin, Forenede Stater, 53715
        • Research Site
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Research Site
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Research Site
      • Neenah, Wisconsin, Forenede Stater, 54956
        • Research Site
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Research Site
    • Wyoming
      • Cheyenne, Wyoming, Forenede Stater, 82001
        • Research Site
      • Arecibo, Puerto Rico, 00612
        • Research Site
      • Bayamon, Puerto Rico, 00961
        • Research Site
      • Guaynabo, Puerto Rico, 00968
        • Research Site
      • Mayaguez, Puerto Rico, 00680
        • Research Site
      • Ponce, Puerto Rico, 00717
        • Research Site

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

US participants with relapsing MS receiving commercial natalizumab.

Beskrivelse

Key Inclusion Criteria:

  • Relapsing MS patients receiving commercial natalizumab
  • Patients receiving natalizumab and their prescribers must be enrolled in the TOUCH Prescribing Program.
  • Patients with suspected or confirmed PML who are at or referred to a participating STRATIFY-2 site may enroll into STRATIFY-2 for purposes of PML sample collection.

Key Exclusion Criteria:

- Patients may participate in any other clinical trial or study sponsored by Biogen Idec ; however, if the anti-JCV antibody test is included in the other clinical study and that study is performing a longitudinal analysis of those samples, the patient should withdraw from STRATIFY-2.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
natalizumab
US participants with relapsing MS receiving commercial natalizumab
Indgives som specificeret i behandlingsarmen
Andre navne:
  • Tysabri
  • BG00002

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Demonstrate that the incidence of PML in natalizumab-treated participants who do not have detectable antibodies to JC virus (JCV) (antibody negative) is lower than in patents who have detectable antibodies to JCV (antibody positive)
Tidsramme: Up to 4 years
Up to 4 years

Sekundære resultatmål

Resultatmål
Tidsramme
Estimate the incidence of PML in natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody positive, based on a meta-analysis of data obtained from this study and other data sources
Tidsramme: Up to 4 years
Up to 4 years
Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program
Tidsramme: Up to 4 years
Up to 4 years
Determine changes in anti-JCV antibody status over time
Tidsramme: Up to 4 years
Up to 4 years

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

1. marts 2010

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. november 2015

Datoer for studieregistrering

Først indsendt

17. februar 2010

Først indsendt, der opfyldte QC-kriterier

17. februar 2010

Først opslået (Skøn)

18. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2016

Sidst verificeret

1. september 2016

Mere information

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 .

Kliniske forsøg med Recidiverende multipel sklerose

Kliniske forsøg med natalizumab

Abonner