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COMPLETED

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

NCT01070836 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG natalizumab

Study Locations (20)

Arizona

  • Research Site — Flagstaff
  • Research Site — Gilbert
  • Research Site — Phoenix
  • Research Site — Phoenix
  • Research Site — Phoenix
  • Research Site — Phoenix
  • Research Site — Scottsdale
  • Research Site — Tucson
  • Research Site — Tucson

Alabama

  • Research Site — Birmingham
  • Research Site — Birmingham
  • Research Site — Cullman
  • Research Site — Tucaloosa

Arkansas

  • Research Site — Fayetteville
  • Research Site — Little Rock
  • Research Site — Sherwood

California

  • Research Site — Auburn
  • Research Site — Berkeley
  • Research Site — Carmel

Alaska

  • Research Site — Anchorage

Trial Details

FieldValue
Enrollment Target 35,895 participants
Start Date 2010-03
Est. Completion 2015-11

Sponsor

Biogen

74 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01070836

The ClinicalTrials.gov registry entry for NCT01070836 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35,895 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention — of which natalizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01070836 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Arizona, Alabama, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01070836 about?

NCT01070836 is a clinical study titled "JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab". 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 ...

What is the current status of trial NCT01070836?

This trial is currently completed. The enrollment target is 35,895 participants. The study started on 2010-03. Estimated completion is 2015-11.

What conditions does trial NCT01070836 study?

This clinical trial studies the following conditions: Relapsing Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01070836?

The interventions under investigation include: natalizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01070836?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01070836 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial