CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 581 enrolled
Drug / intervention
Alemtuzumab +1 morebiological
Likely dose
Alemtuzumab 12 milligramfrom 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/NCT00530348
NCT00530348Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

Genzyme, a Sanofi Company·interventional·Posted Sep 17, 2007·Updated Nov 24, 2014

In Brief

A Phase 3 clinical trial evaluating Alemtuzumab and Interferon beta-1a for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 581 participants across 101 sites in 16 countries.

Detailed Summary

The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesArgentina, Australia, Brazil, Canada, Croatia, Czechia, France, Germany, Mexico, Poland, Russia, Serbia, Sweden, Ukraine, United Kingdom, United States
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 17, 2007
Enrollment StartAug 1, 2007
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.8 years ago

Interventions

Alemtuzumabbiological

Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.

Interferon beta-1abiological

Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.