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ClinicalTrials.gov record
Completed No phase listed Observational

JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab

ClinicalTrials.gov ID: NCT01070836

Public ClinicalTrials.gov record NCT01070836. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 1:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01070836
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Biogen
Industry
Enrollment
35,895 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2010 (Type not available)
Primary completion
Nov 2015 (Actual)
Completion
Nov 2015 (Actual)
Last update posted
Sep 29, 2016

2010 – 2015

United States locations

U.S. sites
473
U.S. states
51
U.S. cities
389
Facility City State ZIP Site status
Research Site Birmingham Alabama 35209 —
Research Site Birmingham Alabama 35233 —
Research Site Cullman Alabama 35058 —
Research Site Tucaloosa Alabama 35406 —
Research Site Anchorage Alaska 99508 —
Research Site Flagstaff Arizona 86001 —
Research Site Gilbert Arizona 85234 —
Research Site Phoenix Arizona 85004 —
Research Site Phoenix Arizona 85013 —
Research Site Phoenix Arizona 85018 —
Research Site Phoenix Arizona 85032 —
Research Site Scottsdale Arizona 85258 —
Research Site Tucson Arizona 85718 —
Research Site Tucson Arizona 85741 —
Research Site Fayetteville Arkansas 72703 —
Research Site Little Rock Arkansas 72205 —
Research Site Sherwood Arkansas 72120 —
Research Site Auburn California 95602 —
Research Site Berkeley California 94705 —
Research Site Carmel California 93923 —
Research Site Carmichael California 95608 —
Research Site Fountain Valley California 92708 —
Research Site Fresno California 93701 —
Research Site Fresno California 93720 —
Research Site Fullerton California 92835 —
Research Site La Jolla California 92037 —
Research Site Loma Linda California 92354 —
Research Site Los Alamitos California 90720 —
Research Site Los Angeles California 90033 —
Research Site Los Angeles California 90073 —
Research Site Marina del Rey California 90292 —
Research Site Modesto California 95355 —
Research Site Newport Beach California 92663 —
Research Site Northridge California 91328 —
Research Site Palo Alto California 94301 —
Research Site Pasadena California 91101 —
Research Site Pasadena California 91105 —
Research Site Redding California 96001 —
Research Site Sacramento California 95816 —
Research Site San Diego California 82117 —
Research Site San Francisco California 94109 —
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Research Site Santa Barbara California 93105 —
Research Site St. Helena California 94574 —
Research Site Stanford California 94305 —
Research Site Stockton California 95204 —
Research Site Thousand Oaks California 91360 —
Research Site Tracy California 95376 —
Research Site Arvada Colorado 80002 —
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Research Site Danbury Connecticut 06810 —
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Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01070836, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 29, 2016 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01070836 live on ClinicalTrials.gov.

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