CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
BG00002-E (natalizumab high titer)biological
Likely dose
Not stated in 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/NCT00516893
NCT00516893Phase 2Completed
CompareCT.gov

A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis

Biogen·interventional·Posted Aug 16, 2007·Updated May 15, 2014

In Brief

A Phase 2 clinical trial evaluating BG00002-E (natalizumab high titer) for Multiple Sclerosis. Completed, enrolled 113 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
CollaboratorsElan Pharmaceuticals

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2007
Enrollment StartOct 1, 2006
Primary CompletionOct 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.9 years ago

Interventions

BG00002-E (natalizumab high titer)biological