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

September 27, 2016 updated by: 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.

Study Overview

Status

Completed

Conditions

Relapsing Multiple Sclerosis

Intervention / Treatment

Drug: natalizumab

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

35895

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

US participants with relapsing MS receiving commercial natalizumab.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
natalizumab US participants with relapsing MS receiving commercial natalizumab	Drug: natalizumab Administered as specified in the treatment arm Other Names: Tysabri BG00002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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) Time Frame: Up to 4 years	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: 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 Time Frame: Up to 4 years	Up to 4 years
Determine changes in anti-JCV antibody status over time Time Frame: Up to 4 years	Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

101JC402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsing Multiple Sclerosis

Biogen

Withdrawn

Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Relapsing-Remitting Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis
The Cleveland Clinic
University Hospitals Cleveland Medical Center

Completed

Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple Sclerosis

United States
University of California, Los Angeles

Unknown

Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition

Relapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple Sclerosis

United States
Biogen
AbbVie

Terminated

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019 (EXTEND)

Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis

United States, Denmark, Italy, United Kingdom, Czechia, Canada, Hungary, Spain, Australia, Israel, Georgia, Serbia, Russian Federation, Ukraine, India, Poland, Brazil, France, Argentina, Germany, Greece, Ireland, Mexico, Moldova, Republic... and more
EMD Serono
Pfizer

Completed

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Relapsing-remitting Multiple Sclerosis

United States, United Kingdom, Argentina, Austria, Brazil, France, Germany, Italy, Netherlands, Russian Federation, Spain, Switzerland
National Institute of Allergy and Infectious Diseases...
Immune Tolerance Network (ITN)

Completed

High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study

Relapsing-Remitting Multiple Sclerosis

United States
Biogen

Terminated

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants (REVEAL)

Relapsing-Remitting Multiple Sclerosis

United States, Spain, Germany, Australia, Sweden, Czechia, France, Italy, United Kingdom
Novartis Pharmaceuticals

Withdrawn

Safety and Efficacy of Fingolimod in MS Patients in China

Multiple Sclerosis (Relapsing Remitting)
Genzyme, a Sanofi Company

Terminated

Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (EMPIRE)

Relapsing-remitting Multiple Sclerosis

Sweden, Poland, Russian Federation, United States, Canada
Novartis Pharmaceuticals

Completed

Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (Biobank)

Relapsing-remitting Multiple Sclerosis

Germany

Clinical Trials on natalizumab

Biogen
Elan Pharmaceuticals; United BioSource, LLC

Completed

JC-Virus (JCV) Antibody Program (STRATIFY-1)

Multiple Sclerosis

United States
Biogen
Elan Pharmaceuticals

Withdrawn

Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy

Crohn's Disease
Biogen
Elan Pharmaceuticals

Completed

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

Crohn's Disease

United States
Biogen

Completed

Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS) (REFINE)

Relapsing-Remitting Multiple Sclerosis

France, Italy, Spain, Germany, Belgium
Biogen
Elan Pharmaceuticals

Completed

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

Crohn's Disease
Biogen
Elan Pharmaceuticals

Completed

Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease

Crohn's Disease

United States
Biogen
Elan Pharmaceuticals

Completed

Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

Crohn's Disease

United States, United Kingdom
University at Buffalo

Completed

Natalizumab Temporary Discontinuation Study (NaTDS)

Multiple Sclerosis

United States
University Hospital, Caen
Biogen

Completed

Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort (RELEVANT)

Multiple Sclerosis, Relapsing-Remitting

France
Biogen

Completed

Ireland Natalizumab (TYSABRI) Observational Program (iTOP)

Relapsing-Remitting Multiple Sclerosis

Ireland

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Relapsing Multiple Sclerosis

Clinical Trials on natalizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations