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

27. september 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Residiverende multippel sklerose

Intervensjon / Behandling

Legemiddel: natalizumab

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

35895

Kontakter og plasseringer

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

Studiesteder

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

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

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort	Intervensjon / Behandling
natalizumab US participants with relapsing MS receiving commercial natalizumab	Legemiddel: natalizumab Administreres som spesifisert i behandlingsarmen Andre navn: Tysabri BG00002

Hva måler studien?

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

Samarbeidspartnere og etterforskere

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

Sponsor

Biogen

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

1. mars 2010

Primær fullføring (Faktiske)

1. november 2015

Studiet fullført (Faktiske)

1. november 2015

Datoer for studieregistrering

Først innsendt

17. februar 2010

Først innsendt som oppfylte QC-kriteriene

17. februar 2010

Først lagt ut (Anslag)

18. februar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. september 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

101JC402

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. .

Kliniske studier på Residiverende multippel sklerose

Biogen

Godkjent for markedsføring

Utvidet tilgangsprogram for Tofersen hos deltakere med Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

Forente stater
Bayer

Fullført

UTOVER Pilotstudie

Multippel sklerose | Relapsing-Remitting

Forente stater
Cinnagen

Fullført

Effekt og sikkerhet av Xacrel® (Ocrelizumab) hos deltakere med residiverende remitterende multippel sklerose

Multippel sklerose | Relapsing-Remitting

Iran, den islamske republikken
Novartis Pharmaceuticals

Fullført

En 12-måneders, åpen etikett, multisenterstudie for å utforske helseresultatene til FTY720

Multippel sklerose | Relapsing-Remitting

Tyrkia
EMD Serono

Avsluttet

Overholdelsesprøve med MS LifeLines ® -tjenester

Multippel sklerose | Relapsing-Remitting

Forente stater
National Institute of Allergy and Infectious Diseases...
Autoimmunity Centers of Excellence

Avsluttet

Behandling av multippel sklerose med Sirolimus, en immunsystemdemper

Multippel sklerose (MS) - Relapsing-remitting

Forente stater
EMD Serono
Merck Serono International SA

Fullført

Tolerabilitet av Rebif®-injeksjon med og uten bruk av Rebijject™Mini hos pasienter med tilbakefallende og remitterende multippel sklerose

Multippel sklerose, relapsing-remitting
Asuman Kucukoner

Fullført

Tale i støydiskrimineringsferdigheter hos multippel sklerosepasienter.

Multippel sklerose-Relapsing-Remitting

Tyrkia
Nantes University Hospital

Har ikke rekruttert ennå

Peer Support-effekt på terapeutisk overholdelse hos pasienter med multippel sklerose (PAIR-SEP)

Multippel sklerose, relapsing-remitting
Johns Hopkins University
University of California, San Francisco; National Multiple Sclerosis Society

Fullført

Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

Multippel sklerose, relapsing-remitting

Forente stater

Kliniske studier på natalizumab

Biogen
Elan Pharmaceuticals; United BioSource, LLC

Fullført

JC-Virus (JCV) antistoffprogram (STRATIFY-1)

Multippel sklerose

Forente stater
Biogen
Elan Pharmaceuticals

Tilbaketrukket

Studie av Tysabri (Natalizumab) hos pasienter som mislyktes med anti-TNF-α-terapi

Crohns sykdom
Biogen
Elan Pharmaceuticals

Fullført

Open Label Natalizumab sikkerhetsutvidelsesstudie for personer med Crohns sykdom

Crohns sykdom

Forente stater
Biogen
Elan Pharmaceuticals

Fullført

Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

Crohns sykdom

Forente stater
Biogen

Fullført

Utforskende studie av sikkerhet, tolerabilitet og effekt av multiple regimer av Natalizumab hos voksne deltakere med residiverende multippel sklerose (MS) (REFINE)

Residiverende-remitterende multippel sklerose

Frankrike, Italia, Spania, Tyskland, Belgia
Biogen
Elan Pharmaceuticals

Fullført

Sikkerhet og effekt av Natalizumab i behandling av Crohns sykdom

Crohns sykdom
Biogen

Fullført

Irland Natalizumab (TYSABRI) observasjonsprogram (iTOP)

Residiverende-remitterende multippel sklerose

Irland
Biogen

Avsluttet

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis (ASCEND in SPMS)

Sekundær progressiv multippel sklerose

Forente stater, Finland, Italia, Spania, Canada, Frankrike, Israel, Sverige, Nederland, Belgia, Polen, Storbritannia, Tsjekkia, Danmark, Den russiske føderasjonen, Tyskland, Irland
Biogen

Avsluttet

Natalizumab som en effektbryter hos deltakere med residiverende multippel sklerose etter feil på andre terapier (ESCALATE)

Residiverende multippel sklerose

Forente stater
Biogen
Elan Pharmaceuticals

Fullført

Natalizumab Re-initiering av dosering

Multippel sklerose, tilbakefallende-remitterende

Forente stater, Canada

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

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

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Prøvetakingsmetode

Studiepopulasjon

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Anslag)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Kliniske studier på Residiverende multippel sklerose

Kliniske studier på natalizumab

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Bosnia & Herzegovina

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder