CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
BG00002 (natalizumab) +2 morebiological
Likely dose
keyhole limpet hemocyanin (KLH) 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00536120
NCT00536120Phase 4Completed
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A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

Biogen·interventional·Posted Sep 27, 2007·Updated Feb 15, 2017

In Brief

A Phase 4 clinical trial evaluating BG00002 (natalizumab), keyhole limpet hemocyanin (KLH), and 1 other intervention for Multiple Sclerosis. Completed, enrolled 60 participants across 10 sites.

Detailed Summary

The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin \[KLH\]) and a recall antigen (tetanus toxoid \[Td\]), and to evaluate the effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess alpha4-integrin saturation and alpha4-integrin expression levels over time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2007
Enrollment StartJan 1, 2008
Primary CompletionNov 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.8 years ago

Interventions

BG00002 (natalizumab)biological

keyhole limpet hemocyanin (KLH)biological

KLH 1 mg administered subcutaneously (SC) in accordance with the Immucothel investigator's brochure.

tetanus diphtheria toxoid vaccine (Td)biological

Td administered in accordance with the manufacturer's prescribing information.