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John Cunningham Virus (JCV) Antibody Study of Multiple Sclerosis (MS) Patients With Relapsing Forms of MS Receiving Treatment With Tysabri (STRATIFY-2)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01070836
First received: February 17, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The primary objective of this study is to demonstrate that the incidence of progressive multifocal Leukoencephalopathy (PML) in Tysabri-treated patients 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).

The secondary objectives of this study are as follows:

  • Estimate the incidence of PML in Tysabri-treated patients 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) patients receiving Tysabri within the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program.
  • Determine changes in anti-JCV antibody status over time.

Condition Intervention
Multiple Sclerosis
Drug: Tysabri

Study Type: Observational
Official Title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Demonstrate that the incidence of PML in Tysabri-treated patients 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: Unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate the incidence of PML in Tysabri-treated patients 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: Unknown ] [ Designated as safety issue: Yes ]
  • Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) patients receiving Tysabri within the TYSABRI Outreach: Unite Commitment to Health (TOUCH) Prescribing Program. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
  • Determine changes in anti-JCV antibody status over time. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Plasma, Serum, Urine, Whole Blood, Peripheral blood mononuclear cell (PBMC)


Estimated Enrollment: 8000
Study Start Date: March 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tysabri-treated Participants with Relapsing MS
United States (US) patients with relapsing MS receiving commercial Tysabri.
Drug: Tysabri
commercial Tysabri

Detailed Description:

No treatment is provided in this observational, longitudinal cohort study. Study population will consist of United States (US) patients with relapsing MS receiving commercial Tysabri. There are no study-mandated visits. Serum samples will be collected during routine patient care or follow-up visits at enrollment into the study and then every 6 months thereafter for up to 4 years after the initial sample collection. Samples will be sent to a central laboratory for analysis (presence of anti-JCV antibody), and remaining serum aliquots will be stored for future Tysabri and PML research. Additional samples will be collected at participating sites from patients who qualify and consent to participate in focused sampling group (patients who are anti-JCV antibody positive at any timepoint AND have received ≥12 infusions of Tysabri, whether or not they have a history of immunosuppressant use). These samples will be stored for future Tysabri and PML research, including biomarker analysis.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

US Patients with relapsing MS receiving commercial Tysabri.

Criteria

Inclusion Criteria:

  • Relapsing MS patients receiving commercial Tysabri
  • Patients receiving Tysabri 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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070836

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Johnstown, Pennsylvania, United States, 15904
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Lititz, Pennsylvania, United States, 17543
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Meadowbrook, Pennsylvania, United States, 19046
Research Site
Monaca, Pennsylvania, United States, 15061
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Monroeville, Pennsylvania, United States, 15146
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Paoli, Pennsylvania, United States, 19301
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Philadelphia, Pennsylvania, United States, 19104
Research Site
Philadelphia, Pennsylvania, United States, 19124
Research Site
Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15206
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Pittsburgh, Pennsylvania, United States, 15212
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
United States, Rhode Island
Research Site
East Providence, Rhode Island, United States, 02914
Research Site
Providence, Rhode Island, United States, 02903
United States, South Carolina
Research Site
Columbia, South Carolina, United States, 29203
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Greenville, South Carolina, United States, 29605
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Mount Pleasant, South Carolina, United States, 29464
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Port Royal, South Carolina, United States, 29935
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Spartanburg, South Carolina, United States, 29302
Research Site
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Research Site
Sioux Falls, South Dakota, United States, 57105
Research Site
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
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Bartlett, Tennessee, United States, 38134
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Chattanooga, Tennessee, United States, 37403
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Chattanooga, Tennessee, United States, 37404
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Columbia, Tennessee, United States, 38401
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Franklin, Tennessee, United States, 37064
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Knoxville, Tennessee, United States, 37934
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Knoxville, Tennessee, United States, 37923
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Nashville, Tennessee, United States, 37205
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Nashville, Tennessee, United States, 73215
United States, Texas
Research Site
Amarillo, Texas, United States, 79106
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Arlington, Texas, United States, 76012
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Austin, Texas, United States, 78705
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Bedford, Texas, United States, 76022
Research Site
Bedford, Texas, United States, 76021
Research Site
Colleyville, Texas, United States, 76034
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Dallas, Texas, United States, 75243
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Dallas, Texas, United States, 75214
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Dallas, Texas, United States, 75390
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Houston, Texas, United States, 77030
Research Site
Houston, Texas, United States, 77054
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Houston, Texas, United States, 77024
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Kerrville, Texas, United States, 78028
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Mansfield, Texas, United States, 76063
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Round Rock, Texas, United States, 78681
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San Antonio, Texas, United States, 78231
Research Site
San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78229
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Wichita Falls, Texas, United States, 79301
United States, Utah
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Ivins, Utah, United States, 84738
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Provo, Utah, United States, 84604
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Salt Lake City, Utah, United States, 84108
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Salt Lake City, Utah, United States, 84103
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Salt Lake City, Utah, United States, 84102
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Salt Lake City, Utah, United States, 84124
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Washington Terrace, Utah, United States, 84405
United States, Vermont
Research Site
Burlington, Vermont, United States, 05401
United States, Virginia
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Alexandria, Virginia, United States, 22310
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Alexandria, Virginia, United States, 22304
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Carrollton, Virginia, United States, 23314
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Centreville, Virginia, United States, 20120
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Charlottesville, Virginia, United States, 22903
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Christiansburg, Virginia, United States, 24073
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Fairfax, Virginia, United States, 22031
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Fredericksburg, Virginia, United States, 22401
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McLean, Virginia, United States, 22101
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Newport News, Virginia, United States, 23601
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Norfolk, Virginia, United States, 23502
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Norfolk, Virginia, United States, 23507
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Richmond, Virginia, United States, 23226
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Roanoke, Virginia, United States, 24018
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Stafford, Virginia, United States, 22556
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Vienna, Virginia, United States, 22182
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Winchester, Virginia, United States, 22601
United States, Washington
Research Site
Auburn, Washington, United States, 98001
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Bellingham, Washington, United States, 98225
Research Site
Burien, Washington, United States, 98166
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Federal Way, Washington, United States, 98003
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Kirkland, Washington, United States, 98034
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Mount Vernon, Washington, United States, 98274
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Renton, Washington, United States, 98055
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Richland, Washington, United States, 99352
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Seattle, Washington, United States, 98195
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Seattle, Washington, United States, 98101
Research Site
Seattle, Washington, United States, 98122
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Silverdale, Washington, United States, 98383
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Spokane, Washington, United States, 99202
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Spokane, Washington, United States, 99204
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Spokane, Washington, United States, 99208
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Tacoma, Washington, United States, 98405
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Wenatchee, Washington, United States, 98801
United States, West Virginia
Research Site
Huntington, West Virginia, United States, 25702
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Point Pleasant, West Virginia, United States, 25550
United States, Wisconsin
Research Site
Green Bay, Wisconsin, United States, 54301
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Green Bay, Wisconsin, United States, 54308
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La Crosse, Wisconsin, United States, 54601
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Madison, Wisconsin, United States, 53715
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Milwaukee, Wisconsin, United States, 53215
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Milwaukee, Wisconsin, United States, 53226
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Neenah, Wisconsin, United States, 54956
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Waukesha, Wisconsin, United States, 53188
United States, Wyoming
Research Site
Cheyenne, Wyoming, United States, 82001
Puerto Rico
Research Site
Arecibo, Puerto Rico, 00612
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Bayamon, Puerto Rico, 00961
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Guayambo, Puerto Rico, 00968
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Mayaguez, Puerto Rico, 00680
Research Site
Ponce, Puerto Rico, 00717
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01070836     History of Changes
Other Study ID Numbers: 101JC402
Study First Received: February 17, 2010
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
JCV
Sample Collection
PML
Antibody

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014