Loading clinical trials...
Loading clinical trials...
A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
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.
The total duration per participants was up to 5.6 years. As per Study Investigator discretion, participants can be treated with additional courses of alemtuzumab or any commercialized DMTs. All participants who completed CAMMS03409 were allowed into the study, which might include specific vulnerable populations. If the investigator decided to treat a participant with a course of alemtuzumab, appropriate cautionary measures were applied as indicated in the approved labelling, or, in ex-European Union countries where Lemtrada was not approved, according to the investigator's brochure.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Investigational Site Number 1086
Cullman, Alabama, United States
Investigational Site Number 1031
Phoenix, Arizona, United States
Investigational Site Number 1171
Phoenix, Arizona, United States
Investigational Site Number 1090
Tucson, Arizona, United States
Investigational Site Number 1040
Berkeley, California, United States
Investigational Site Number 1152
Fullerton, California, United States
Investigational Site Number 1093
Pasadena, California, United States
Investigational Site Number 1027
Fort Collins, Colorado, United States
Investigational Site Number 1078
Jacksonville, Florida, United States
Investigational Site Number 1059
Maitland, Florida, United States
Start Date
January 7, 2015
Primary Completion Date
July 15, 2020
Completion Date
July 15, 2020
Last Updated
March 28, 2022
1,062
ACTUAL participants
alemtuzumab GZ402673
DRUG
Lead Sponsor
Genzyme, a Sanofi Company
NCT04047628
NCT04602390
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions