CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,062 enrolled
Drug / intervention
alemtuzumab GZ402673drug
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/NCT02255656
NCT02255656Phase 4Completed
CompareCT.gov

A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)

Genzyme, a Sanofi Company·interventional·Posted Oct 2, 2014·Updated Mar 28, 2022

In Brief

A Phase 4 clinical trial evaluating alemtuzumab GZ402673 for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 1,062 participants across 131 sites in 19 countries.

Detailed Summary

Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: * To evaluate long term efficacy of alemtuzumab. * To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. * To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. * To evaluate as needed re-treatment with alemtuzumab and other DMTs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
CountriesArgentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Germany, Israel, Italy, Mexico, Netherlands, Poland, Russia, Spain, Sweden, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2, 2014
Enrollment StartJan 7, 2015
Primary CompletionJul 15, 2020
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 11.8 years ago

Interventions

alemtuzumab GZ402673drug

Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous