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NCT00516893 · ClinicalTrials.gov registry record · Phase 2

Natalizumab High Titer Immunogenicity and Safety

A Phase 2 study of Multiple Sclerosis, sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
113
Enrollment target
13
Study locations

NCT00516893 is a Phase 2 study of Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 113 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (81% lower). The trial reports 13 study locations across 9 states.

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The verdict

NCT00516893, a Phase 2 study of Multiple Sclerosis, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
113 participants
Enrollment target
13
Study locations

Study Summary

The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of this study was to evaluate the safety of natalizumab high titer.

Conditions Studied

Multiple Sclerosis

Interventions

  • BIOLOGICAL BG00002-E (natalizumab high titer)

Study Locations (13)

Florida

  • Research Site - Maitland
  • Research Site - Miami

New York

  • Research Site - Buffalo
  • Research Site - New York

Pennsylvania

  • Research Site - Philadelphia
  • Research Site - Pittsburgh

Texas

  • Research Site - Dallas
  • Research site - Round Rock

District of Columbia

  • Research Site - Washington D.C.

Georgia

  • Research Site - Atlanta

Michigan

  • Research Site - Farmington Hills

North Carolina

  • Research Site - Charlotte

Trial Details

FieldValue
Enrollment Target 113 participants
Start Date 2006-10
Est. Completion 2007-12
Phase Phase 2

Sponsor

Biogen

334 total trials

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What the Registry Record Tells You About NCT00516893

The ClinicalTrials.gov registry entry for NCT00516893 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (81% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which BG00002-E (natalizumab high titer) is the first listed.

NCT00516893 reports 13 study locations spanning 9 distinct geographic areas - top geographies include Florida, New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00516893 about?

NCT00516893 is a clinical study titled "Natalizumab High Titer Immunogenicity and Safety". The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of...

What is the current status of trial NCT00516893?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2006-10. Estimated completion is 2007-12.

What conditions does trial NCT00516893 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT00516893?

The interventions under investigation include: BG00002-E (natalizumab high titer) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00516893?

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

Where is trial NCT00516893 being conducted?

This trial has 13 study locations across District of Columbia, Florida, Georgia, Michigan, New York. 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.