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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT01070836
Collaborator
(none)
35,895
Enrollment
478
Locations
68
Duration (Months)
75.1
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
35895 participants
Official Title:
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
natalizumab

US participants with relapsing MS receiving commercial natalizumab

Drug: natalizumab
Administered as specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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) [Up to 4 years]

    Secondary Outcome Measures

    1. 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 [Up to 4 years]

    2. Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program [Up to 4 years]

    3. Determine changes in anti-JCV antibody status over time [Up to 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT01070836
    Other Study ID Numbers:
    • 101JC402
    First Posted:
    Feb 18, 2010
    Last Update Posted:
    Sep 29, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Biogen
    JCV
    Sample Collection
    PML
    Antibody
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Natalizumab

    Study Results

    No Results Posted as of Sep 29, 2016