JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab (STRATIFY-2)
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2
Sponsor: Biogen
A observational or N/A phase clinical study on Relapsing Multiple Sclerosis, this trial is completed. The trial is conducted by Biogen and has accumulated 13 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
13 versions recorded-
Jan 2026 — Present [monthly]
Completed
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Sep 2025 — Present [monthly]
Completed
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Sep 2024 — Sep 2025 [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Dec 2021 — Jul 2024 [monthly]
Completed
▶ Show 8 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Completed
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Nov 2020 — Jan 2021 [monthly]
Completed
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Jun 2018 — Nov 2020 [monthly]
Completed
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May 2018 — Jun 2018 [monthly]
Completed
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Apr 2018 — May 2018 [monthly]
Completed
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Completed NA
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Feb 2017 — Aug 2017 [monthly]
Completed NA
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Jan 2017 — Feb 2017 [monthly]
Completed NA
First recorded
Mar 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Biogen
For direct contact, visit the study record on ClinicalTrials.gov .