Relapsing Multiple SclerosisSTRATIFY-2NCT01070836

JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab

An observational study of Relapsing Multiple Sclerosis, run by Biogen at 478 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Relapsing Multiple Sclerosis
What is being tested?: natalizumab
How many people: 35,895 participants
Where: 478 sitesin 2 countries
Study dates: Mar 2010to Nov 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: US participants with relapsing MS receiving commercial natalizumab.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

478 sites in 2 countries.

Country

City, postcode or hospital

305 sites in 2 countries

United States300 sites

Research Site
Abington, Pennsylvania, 19001
Research Site
Advance, North Carolina, 27006
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Akron, Ohio, 44320
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Albany, New York, 12205
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Albany, New York, 12206
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Albany, New York, 12208
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Albuquerque, New Mexico, 87106
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Alexandria, Louisiana, 71301
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Alexandria, Virginia, 22304
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Alexandria, Virginia, 22310
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Allentown, Pennsylvania, 18103
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Allentown, Pennsylvania, 18104
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Altoona, Pennsylvania, 16602
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Amarillo, Texas, 79106
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Ames, Iowa, 80010
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Amherst, New York, 14226
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Anchorage, Alaska, 99508
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Anderson, Indiana, 46016
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Ann Arbor, Michigan, 48109
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Annapolis, Maryland, 21401
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Arlington, Texas, 76012
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Arvada, Colorado, 80002
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Asheville, North Carolina, 28806
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Athens, Georgia, 30606
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Atlanta, Georgia, 30309
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Atlanta, Georgia, 30312
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Atlanta, Georgia, 30322
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Atlanta, Georgia, 30327
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Attleboro, Massachusetts, 02703
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Auburn, California, 95602
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Auburn, Washington, 98001
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Aurora, Colorado, 80045
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Austin, Texas, 78705
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21287
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Bartlett, Tennessee, 38134
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Basalt, Colorado, 81621
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Baton Rouge, Louisiana, 70809
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Baton Rouge, Louisiana, 70810
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Bay Shore, New York, 11706
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Bayonne, New Jersey, 07002
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Bedford, Texas, 76021
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Belfast, Maine, 04915
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Bellevue, Ohio, 44811
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Bellingham, Washington, 98225
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Bend, Oregon, 97701
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Berkeley, California, 94705
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Bethesda, Maryland, 20814
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Bethlehem, Pennsylvania, 18015
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Billings, Montana, 59101
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Bingham Farms, Michigan, 48025
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Birmingham, Alabama, 35209
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Birmingham, Alabama, 35233
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Bismarck, North Dakota, 58501
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Bloomington, Illinois, 61701
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Bloomington, Illinois, 61704
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Bloomington, Indiana, 47403
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Boise, Idaho, 83706
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Boone, North Carolina, 28607
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Boston, Massachusetts, 02111
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Boston, Massachusetts, 02135
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Boston, Massachusetts, 02215
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Brackenridge, Pennsylvania, 15014
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Bradenton, Florida, 34205
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Brookline, Massachusetts, 02445
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Brooklyn, New York, 11215
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Brooklyn, New York, 11219
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Brooklyn, New York, 11220
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Buffalo, New York, 14203
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Burien, Washington, 98166
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Burlington, Massachusetts, 01805
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Burlington, Vermont, 05401
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Camillus, New York, 13031
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Canton, Ohio, 44718
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Carmel, California, 93923
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Carmichael, California, 95608
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Carrollton, Virginia, 23314
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Cedarhurst, New York, 11516
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Centennial, Colorado, 80112
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Centreville, Virginia, 20120
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Champaign, Illinois, 61820
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Chapel Hill, North Carolina, 27599
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Charlotte, North Carolina, 28203
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Charlotte, North Carolina, 28204
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Charlotte, North Carolina, 28207
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Charlottesville, Virginia, 22903
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Chattanooga, Tennessee, 37403
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Chattanooga, Tennessee, 37404
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Cheyenne, Wyoming, 82001
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Chicago, Illinois, 60611
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Chicago, Illinois, 60612
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Chicago, Illinois, 60616
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Chicago, Illinois, 60637
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Christiansburg, Virginia, 24073
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Cincinnati, Ohio, 45219
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Cinton Township, Michigan, 48035
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Clackamas, Oregon, 97015
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44119
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Cleveland, Ohio, 44195
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Collegeville, Pennsylvania, 19426
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Colleyville, Texas, 76034
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80920
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Columbia, South Carolina, 29203
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Columbia, Tennessee, 38401
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Columbus, Georgia, 31909
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Columbus, Ohio, 43210
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Columbus, Ohio, 43221
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Concord, North Carolina, 28025
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Corning, New York, 14830
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Corvallis, Oregon, 97330
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Cullman, Alabama, 35058
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Dallas, Texas, 75214
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Dallas, Texas, 75243
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Dallas, Texas, 75390
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Danbury, Connecticut, 06810
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Danville, Pennsylvania, 17822
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Dayton, Ohio, 45417
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Denver, Colorado, 80205
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Denville, New Jersey, 07834
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Derby, Connecticut, 06418
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Des Moines, Iowa, 50309
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Des Moines, Iowa, 50314
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Detroit, Michigan, 48201
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Detroit, Michigan, 48202
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Dover, Delaware, 19901
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Duncansville, Pennsylvania, 16635
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Durham, North Carolina, 37710
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East Lansing, Michigan, 48824
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East Meadow, New York, 11554
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East Providence, Rhode Island, 02914
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East Syracuse, New York, 13057
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Edison, New Jersey, 08820
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Elk Grove Village, Illinois, 60007
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Elkhart, Indiana, 46514
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Elmhurst, Illinois, 60126
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Erie, Pennsylvania, 16507
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Evanston, Illinois, 60201
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Evansville, Indiana, 47715
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Fairfax, Virginia, 22031
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Fairfield, Connecticut, 06824
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Fargo, North Dakota, 58103
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Farmington Hills, Michigan, 48334
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Fayetteville, Arkansas, 72703
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Federal Way, Washington, 98003
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Flagstaff, Arizona, 86001
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Flemington, New Jersey, 08822
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Flossmoor, Illinois, 60422
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Flushing, New York, 11365
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Fort Collins, Colorado, 80525
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Fort Collins, Colorado, 80528
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Fort Lauderdale, Florida, 33308
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Fort Walton Beach, Florida, 32547
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Fort Wayne, Indiana, 76845
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Fountain Valley, California, 92708
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Franklin, Ohio, 45005
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Franklin, Tennessee, 37064
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Frederick, Maryland, 21702
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Fredericksburg, Virginia, 22401
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Freehold, New Jersey, 07728
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Fresh Meadows, New York, 11365
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Fresno, California, 93701
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Fresno, California, 93720
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Fullerton, California, 92835
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Gahanna, Ohio, 43230
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Gainesville, Florida, 32607
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Gilbert, Arizona, 85234
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Golden Valley, Minnesota, 55422
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Grand Forks, North Dakota, 58201
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Grand Rapids, Michigan, 49525
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Great Falls, Montana, 59405
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Great Neck, New York, 11021
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Greeley, Colorado, 80631
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Green Bay, Wisconsin, 54301
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Green Bay, Wisconsin, 54308
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Greensboro, North Carolina, 27405
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Greensburg, Pennsylvania, 15601
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Greenville, North Carolina, 27834
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Greenville, South Carolina, 29605
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Greenwood, Mississippi, 38930
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Hagerstown, Maryland, 21742
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Harrisburg, Pennsylvania, 17111
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Hartford, Connecticut, 06105
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Hartford, Connecticut, 06112
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Hastings, Nebraska, 68901
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Hattiesburg, Mississippi, 39401
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Hays, Kansas, 67601
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Henderson, North Carolina, 27536
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Hendersonville, North Carolina, 28792
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Herrin, Illinois, 62948
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Hershey, Pennsylvania, 17033
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High Point, North Carolina, 27262
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96813
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Houston, Texas, 77024
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Houston, Texas, 77030
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Huntington, West Virginia, 25702
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Idaho Falls, Idaho, 83404
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Indianapolis, Indiana, 46256
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Indianapolis, Indiana, 46260
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Iowa City, Iowa, 52242
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Ivins, Utah, 84738
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Jacksonville, Florida, 32209
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Jacksonville Beach, Florida, 32250
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Johns Creek, Georgia, 30097
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Johnstown, Pennsylvania, 15904
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Kalamazoo, Michigan, 49007
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Kalamazoo, Michigan, 49048
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Kansas City, Kansas, 66160
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Kansas City, Missouri, 64111
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Kerrville, Texas, 78028
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Kingston, New York, 12401
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Kirkland, Washington, 98034
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Knoxville, Tennessee, 37923
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Knoxville, Tennessee, 37934
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La Crosse, Wisconsin, 54601
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La Jolla, California, 92037
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Lacombe, Louisiana, 70445
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Lafayette, Indiana, 47905
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Lafayette, Louisiana, 70506
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Lake Barrington, Illinois, 60010
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Lake Success, New York, 11042
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Las Vegas, Nevada, 89102
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Latham, New York, 12110
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Lawrenceville, New Jersey, 08648
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Lebanon, New Hampshire, 03766
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Lenexa, Kansas, 66214
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Lewiston, Maine, 04240
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Lexington, Kentucky, 40513
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Lexington, Kentucky, 40536
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Lighthouse PT, Florida, 33064
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Lincoln, Nebraska, 68521
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Lititz, Pennsylvania, 17543
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Little Rock, Arkansas, 72205
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Livingston, New Jersey, 07039
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Loma Linda, California, 92354
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Lombard, Illinois, 60148
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Los Alamitos, California, 90720
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Los Angeles, California, 90033
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Los Angeles, California, 90073
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Louisville, Kentucky, 40207
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Macon, Georgia, 31210
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Madison, Wisconsin, 53715
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Maitland, Florida, 32751
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Mansfield, Texas, 76063
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Marina del Rey, California, 90292
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McLean, Virginia, 22101
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Meadowbrook, Pennsylvania, 19046
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Medford, Oregon, 97504
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Melbourne, Florida, 32901
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Melrose Park, Illinois, 60160
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Meridian, Idaho, 83642
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Merrillville, Indiana, 46410
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Miami, Florida, 33133
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Miami, Florida, 33136
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Midland, Michigan, 48640
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Milford, Massachusetts, 01757
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Milwaukee, Wisconsin, 53215
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Milwaukee, Wisconsin, 53226
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Mineola, New York, 11501
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Minneapolis, Minnesota, 55404
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Minneapolis, Minnesota, 55414
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Mishawaka, Indiana, 46545
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Missoula, Montana, 59802
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Modesto, California, 95355
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Monaca, Pennsylvania, 15061
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Monroeville, Pennsylvania, 15146
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Mooresville, North Carolina, 28117
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Mount Kisco, New York, 10549
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Mount Vernon, Washington, 98274
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Mt. Pleasant, South Carolina, 29464
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Muskegon, Michigan, 49444
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Nampa, Idaho, 83687
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Naples, Florida, 34102
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Nashville, Tennessee, 37205
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Nashville, Tennessee, 73215
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Neenah, Wisconsin, 54956
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New Brunswick, New Jersey, 08901
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New Haven, Connecticut, 06510
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New Hyde Park, New York, 11040
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New London, Connecticut, 06320
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New Orleans, Louisiana, 70112
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New Orleans, Louisiana, 70115
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New York, New York, 10016
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New York, New York, 10019
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New York, New York, 10022
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New York, New York, 10029
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New York, New York, 10065
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Newark, Delaware, 19713
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Newark, New Jersey, 07103
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Newark, New York, 14513
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Newark, Ohio, 43055
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Newport Beach, California, 92663
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Newport News, Virginia, 23601
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Niles, Illinois, 60714
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Nixa, Missouri, 65714
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Norfolk, Nebraska, 68701
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Norfolk, Virginia, 23502
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Norfolk, Virginia, 23507

Other trials in United States

Puerto Rico5 sites

Research Site
Arecibo, 00612
Research Site
Bayamón, 00961
Research Site
Guaynabo, 00968
Research Site
Mayagüez, 00680
Research Site
Ponce, 00717

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Conditions: Relapsing Multiple Sclerosis
Being tested: natalizumab
Keywords: JCV, Sample Collection, PML, Antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

natalizumabDrug
Also called Tysabri, BG00002
Administered as specified in the treatment arm

Study groups in NCT01070836
Study group	Role	What they receive
natalizumab		US participants with relapsing MS receiving commercial natalizumab Receives: Drug: natalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Up to 4 years

Secondary outcomes (3)

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
Measured: Up to 4 years
Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program
Measured: Up to 4 years
Determine changes in anti-JCV antibody status over time
Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Nov 2015

First posted18 Feb 2010 (estimated)
Study startMar 2010
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Enrolment: 35,895 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070836
Sponsor's protocol ID: 101JC402
Acronym: STRATIFY-2
Status last verified: Sep 2016
First submitted: 17 Feb 2010
Last updated: 29 Sep 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Multiple Sclerosis
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)

All Relapsing Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2
ClinicalTrials.gov ID: NCT01070836
Acronym / sponsor ID: STRATIFY-2 / 101JC402
Conditions: Relapsing Multiple Sclerosis
Keywords: JCV, Sample Collection, PML, Antibody
Study type: Observational
Recruitment status: Completed
Enrolment: 35,895 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 18 Feb 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Number of arms: 1

Arm	Type	Receives
natalizumab	–	Drug: natalizumabUS participants with relapsing MS receiving commercial natalizumab

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: US participants with relapsing MS receiving commercial natalizumab.

Key inclusion criteria (3 listed)

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 (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
natalizumabAlso: Tysabri, BG00002Administered as specified in the treatment arm	Drug	natalizumab

Primary outcome

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

3 secondary outcomes

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
Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program
Time frame: Up to 4 years
Determine changes in anti-JCV antibody status over time
Time frame: Up to 4 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.

Related trials for Relapsing Multiple Sclerosis

Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Multiple Sclerosis
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

478 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsing Multiple Sclerosis, run by Biogen at 478 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 478 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01070836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.