Clinical trial NCT01070836: JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
Official title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Keywords: JCV
Sample Collection
PML
Antibody
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 35895
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: US participants with relapsing MS receiving commercial natalizumab.

Brief 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 (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.

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.

Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: Up to 4 years
Secondary outcomes:
measure: 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
timeFrame: Up to 4 years
measure: Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program
timeFrame: Up to 4 years
measure: Determine changes in anti-JCV antibody status over time
timeFrame: Up to 4 years
Other outcomes:
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country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Stony Brook
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: West Seneca
country: United States
facility: Research Site
state: New York
city: White Plains
country: United States
facility: Research Site
state: New York
city: Williamsville
country: United States
facility: Research Site
state: New York
city: Woodmere
country: United States
facility: Research Site
state: New York
city: Advance
country: United States
facility: Research Site
state: North Carolina
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Boone
country: United States
facility: Research Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Concord
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Hendersonville
country: United States
facility: Research Site
state: North Carolina
city: Henderson
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Mooresville
country: United States
facility: Research Site
state: North Carolina
city: Pinehurst
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston Salem
country: United States
facility: Research Site
state: North Carolina
city: Bismarck
country: United States
facility: Research Site
state: North Dakota
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Grand Forks
country: United States
facility: Research Site
state: North Dakota
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Bellevue
country: United States
facility: Research Site
state: Ohio
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Franklin
country: United States
facility: Research Site
state: Ohio
city: Gahanna
country: United States
facility: Research Site
state: Ohio
city: Newark
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Uniontown
country: United States
facility: Research Site
state: Ohio
city: Youngstown
country: United States
facility: Research Site
state: Ohio
city: Zanesville
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Bend
country: United States
facility: Research Site
state: Oregon
city: Clackamas
country: United States
facility: Research Site
state: Oregon
city: Corvallis
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Roseburg
country: United States
facility: Research Site
state: Oregon
city: Tulatin
country: United States
facility: Research Site
state: Oregon
city: Abington
country: United States
facility: Research Site
state: Pennsylvania
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Bethlehem
country: United States
facility: Research Site
state: Pennsylvania
city: Brackenridge
country: United States
facility: Research Site
state: Pennsylvania
city: Collegeville
country: United States
facility: Research Site
state: Pennsylvania
city: Danville
country: United States
facility: Research Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Erie
country: United States
facility: Research Site
state: Pennsylvania
city: Greensburg
country: United States
facility: Research Site
state: Pennsylvania
city: Harrisburg
country: United States
facility: Research Site
state: Pennsylvania
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Research Site
state: Pennsylvania
city: Lititz
country: United States
facility: Research Site
state: Pennsylvania
city: Meadowbrook
country: United States
facility: Research Site
state: Pennsylvania
city: Monaca
country: United States
facility: Research Site
state: Pennsylvania
city: Monroeville
country: United States
facility: Research Site
state: Pennsylvania
city: Paoli
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Research Site
state: Pennsylvania
city: Tarentum
country: United States
facility: Research Site
state: Pennsylvania
city: Upland
country: United States
facility: Research Site
state: Pennsylvania
city: Washington
country: United States
facility: Research Site
state: Pennsylvania
city: West Reading
country: United States
facility: Research Site
state: Pennsylvania
city: York
country: United States
facility: Research Site
state: Pennsylvania
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Port Royal
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Research Site
state: South Dakota
city: Sioux Falls
country: United States
facility: Research Site
state: South Dakota
city: Bartlett
country: United States
facility: Research Site
state: Tennessee
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Columbia
country: United States
facility: Research Site
state: Tennessee
city: Franklin
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Arlington
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Bedford
country: United States
facility: Research Site
state: Texas
city: Colleyville
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Kerrville
country: United States
facility: Research Site
state: Texas
city: Mansfield
country: United States
facility: Research Site
state: Texas
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Research Site
state: Texas
city: Ivins
country: United States
facility: Research Site
state: Utah
city: Provo
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Washington Terrace
country: United States
facility: Research Site
state: Utah
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Alexandria
country: United States
facility: Research Site
state: Virginia
city: Alexandria
country: United States
facility: Research Site
state: Virginia
city: Carrollton
country: United States
facility: Research Site
state: Virginia
city: Centreville
country: United States
facility: Research Site
state: Virginia
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Christiansburg
country: United States
facility: Research Site
state: Virginia
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Fredericksburg
country: United States
facility: Research Site
state: Virginia
city: McLean
country: United States
facility: Research Site
state: Virginia
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Stafford
country: United States
facility: Research Site
state: Virginia
city: Vienna
country: United States
facility: Research Site
state: Virginia
city: Winchester
country: United States
facility: Research Site
state: Virginia
city: Auburn
country: United States
facility: Research Site
state: Washington
city: Bellingham
country: United States
facility: Research Site
state: Washington
city: Burien
country: United States
facility: Research Site
state: Washington
city: Federal Way
country: United States
facility: Research Site
state: Washington
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Mount Vernon
country: United States
facility: Research Site
state: Washington
city: Renton
country: United States
facility: Research Site
state: Washington
city: Richland
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Silverdale
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Wenatchee
country: United States
facility: Research Site
state: Washington
city: Huntington
country: United States
facility: Research Site
state: West Virginia
city: Point Pleasant
country: United States
facility: Research Site
state: West Virginia
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: La Crosse
country: United States
facility: Research Site
state: Wisconsin
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Neenah
country: United States
facility: Research Site
state: Wisconsin
city: Waukesha
country: United States
facility: Research Site
state: Wisconsin
city: Cheyenne
country: United States
facility: Research Site
state: Wyoming
city: Arecibo
country: Puerto Rico
facility: Research Site
city: Bayamon
country: Puerto Rico
facility: Research Site
city: Guaynabo
country: Puerto Rico
facility: Research Site
city: Mayaguez
country: Puerto Rico
facility: Research Site
city: Ponce
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: