Brief Summary
The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.
Brief Title
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
Categories
Completion Date
Completion Date Type
Actual
Conditions
Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
* Patients that as part of their routine clinical care and according to the locally approved label, are either;
* Starting fingolimod at time of study entry.
* Starting another approved DMT or started within maximum 6 months prior to study entry.
* Patients, or a able legal representative of the patient, who are willing to provide written informed consent.
Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort
Exclusion Criteria:
* Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
* Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum
Other protocol-defined inclusion/exclusion criteria may apply
* Patients that as part of their routine clinical care and according to the locally approved label, are either;
* Starting fingolimod at time of study entry.
* Starting another approved DMT or started within maximum 6 months prior to study entry.
* Patients, or a able legal representative of the patient, who are willing to provide written informed consent.
Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort
Exclusion Criteria:
* Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
* Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum
Other protocol-defined inclusion/exclusion criteria may apply
Inclusion Criteria
Inclusion Criteria:
* Patients that as part of their routine clinical care and according to the locally approved label, are either;
* Starting fingolimod at time of study entry.
* Starting another approved DMT or started within maximum 6 months prior to study entry.
* Patients, or a able legal representative of the patient, who are willing to provide written informed consent.
Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort
inclusion/ inclusion/
* Patients that as part of their routine clinical care and according to the locally approved label, are either;
* Starting fingolimod at time of study entry.
* Starting another approved DMT or started within maximum 6 months prior to study entry.
* Patients, or a able legal representative of the patient, who are willing to provide written informed consent.
Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort
inclusion/ inclusion/
Gender
All
Gender Based
false
Keywords
Multiple sclerosis
fingolimod
observational study
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT01442194
Org Class
Industry
Org Full Name
Novartis
Org Study Id
CFTY720D2403
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy
Primary Outcomes
Outcome Description
Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections
Outcome Measure
For each of the selected safety outcomes, number of patients with a reported event since study start
Outcome Time Frame
Patients will be followed for an expected average of 5 years
Secondary Outcomes
Outcome Time Frame
Patients will be followed for an expected average of 5 years
Outcome Measure
Number of patients SAEs since study start
Outcome Time Frame
Patients will be followed for an expected average of 5 years
Outcome Measure
PRIMUS activities, comparison of mean change between the 2 cohorts
Outcome Time Frame
Patients will be followed for an expected average of 5 years
Outcome Measure
TSQM-9, comparison between the 2 cohorts
Outcome Time Frame
Patients will be followed for an expected average of 5 years
Outcome Measure
WPAI-GH, comparison of mean change between the 2 cohorts
Outcome Time Frame
Patients will be followed for an expected average of 5 years
Outcome Measure
MSIS-29, comparison of mean change between the 2 cohorts
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients with relapsing forms of MS that have been recently initiated on fingolimod by their treating physician or patients that are treated with other disease-modifying therapies as part of their MS treatment in accordance with the respective local prescribing information and routine clinical practice
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jerome Graber
Investigator Email
jgraber@montefiore.org
Investigator Phone
718-920-5505
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
MULTIPLE SCLEROSIS
DEMYELINATING AUTOIMMUNE DISEASES, CNS
AUTOIMMUNE DISEASES OF THE NERVOUS SYSTEM
NERVOUS SYSTEM DISEASES
DEMYELINATING DISEASES
AUTOIMMUNE DISEASES
IMMUNE SYSTEM DISEASES
FINGOLIMOD HYDROCHLORIDE
SPHINGOSINE
AMINO ALCOHOLS
ALCOHOLS
ORGANIC CHEMICALS
PROPYLENE GLYCOLS
GLYCOLS
AMINES