Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-19 @ 7:22 AM
Study NCT ID:
NCT02255656
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2014-09-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Sponsor:
Genzyme, a Sanofi Company
Organization:
Study Overview
Official Title:
A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPAZ
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: