A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409)
Published:
Last updated:
To evaluate the long-term safety and efficacy of alemtuzumab, for patients already treated with this medicine in preceding clinical trials (CARE-MS I, CARE-MS II and CAMMS03409).
Lemtrada, Long-term, Multiple sclerosis, Open label
Outcome measures
Primary outcome
To evaluate long-term safety of alemtuzumab.
Secondary outcome
* To evaluate long term efficacy of alemtuzumab
* To evaluate the safety profile of patients who received other disease
modifying therapy following alemtuzumab treatment
* To evaluate patient-reported quality of life (QoL) outcomes and health
resource utilization of patients who received alemtuzumab
* To evaluate as needed re-treatment with alemtuzumab and other disease
modifying therapies
Background summary
Multiple sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that affects approximately 2.5 million people worldwide. MS represents the leading cause of neurologic disability in young and middle-aged adults. It isestimated that as many as 80% of all MS patients present with relapsing remitting MS (RRMS).
LEMTRADA, is a humanized monoclonal antibody administered intravenously that has been approved in the European Union for the treatment of active RRMS.
Study objective
To evaluate the long-term safety and efficacy of alemtuzumab, for patients already treated with this medicine in preceding clinical trials (CARE-MS I, CARE-MS II and CAMMS03409).
Study design
Multicenter, multinational, phase 3b/4.
Intervention
Drug: alemtuzumab (GZ402673, Lemtrada); Pharmaceutical form: Concentrate for solution for infusion; Route of administration: intravenous.
Study burden and risks
Identified risks of LEMTRADA in patients with MS include: - Autoimmunity (ITP, nephropathies, thyroid disorders) - Infections - Infusion-associated reactions (IARs)
Public
Sanofi-aventis
Kampenringweg 45 E Gouda 2803 PE NL
Scientific
Sanofi-aventis
Kampenringweg 45 E Gouda 2803 PE NL
Listed location countries
Netherlands
Age
Adults (18-64 years)
Elderly (65 years and older)
Inclusion criteria
- Patient has completed at least 48 months of the Extension Study CAMMS03409 - Signed written informed consent form
Exclusion criteria
- Patient participating in another investigational interventional study
Design
Study phase
:
4
Study type
:
Interventional
Masking
:
Open (masking not used)
Control
:
Uncontrolled
Primary purpose
:
Treatment
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated)
:
Enrollment
:
3
Type
:
Actual
Medical products/devices used
Product type
:
Medicine
Brand name
:
Lemtrada
Generic name
:
alemtuzumab
Registration
:
Yes - NL intended use
Approved WMO
Date
:
Application type
:
First submission
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
First submission
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date
:
Application type
:
Amendment
Review commission
:
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
