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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01070836
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date February 17, 2010
First Posted Date February 18, 2010
Last Update Posted Date September 29, 2016
Study Start Date March 2010
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2015)
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 ]
Original Primary Outcome Measures
 (submitted: February 17, 2010)
Correlation of JCV Antibody positivity and development of PML.
Change History
Current Secondary Outcome Measures
 (submitted: July 9, 2015)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: February 17, 2010)
Define the sero prevalence of JCV Antibody in this US representative sample of MS patients. [ Time Frame: 2 Years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma, Serum, Urine, Whole Blood, Peripheral blood mononuclear cell (PBMC)
Sampling Method Probability Sample
Study Population US participants with relapsing MS receiving commercial natalizumab.
Condition Relapsing Multiple Sclerosis
Intervention Drug: natalizumab
Administered as specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002
Study Groups/Cohorts natalizumab
US participants with relapsing MS receiving commercial natalizumab
Intervention: Drug: natalizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 27, 2016)
35895
Original Estimated Enrollment
 (submitted: February 17, 2010)
8000
Actual Study Completion Date November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01070836
Other Study ID Numbers 101JC402
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date September 2016