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NCT01070836 · ClinicalTrials.gov registry record

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

A clinical trial of Relapsing Multiple Sclerosis, sponsored by Biogen.

Completed
Registry status
35,895
Enrollment target
20
Study locations

NCT01070836 is a study of Relapsing Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 35,895 participants, above the 609-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (5794% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT01070836, a study of Relapsing Multiple Sclerosis, has completed, sponsored by Biogen.

COMPLETED
Registry status
35,895 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Relapsing Multiple Sclerosis

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

334 total trials

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What the Registry Record Tells You About NCT01070836

The ClinicalTrials.gov registry entry for NCT01070836 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 35,895 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 609-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (5794% higher). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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.

NCT01070836 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Arizona, Alabama, Arkansas.

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.

What interventions are being tested in trial NCT01070836?

The interventions under investigation include: natalizumab (DRUG).

Who is sponsoring clinical trial NCT01070836?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.