Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.
PURPOSE: To investigate whether polymorphic differences can be identified between Multiple sclerosis (MS) patients treated by fingolimod who had liver enzymes elevation compared to those who do not.
OBJECTIVE: To determine whether elevated liver enzyme tests (ALT, AST, GGT or bilirubinemia above the upper limit of normal) in MS patients treated with fingolimod is associated with genetic polymorphisms.
METHOD OF RECRUITMENT:
Patients will be identified through a clinic database and chart reviews. A phone call will be made to determine interest. Upon a follow-up neurological consultation, consent into study will be sought.
PROCEDURES:
Blood samples will be collected for genetic analyses, fingolimod and fingolimod-phosphate quantification and a questionnaire will be administered
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | MS patients treated with fingolimod who experienced liver enzymes elevation |
| |
| Control | MS patients treated with fingolimod not experiencing elevated liver enzymes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic polymorphism | Genetic | One blood tube will be taken for genetic testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| CYP4F2 polymorphism frequency in case and control groups | Proportion of CYP4F2 polymorphism in case and control groups | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Fingolimod concentrations in case and control groups | Trough concentration of fingolimod in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS) | At inclusion |
| Fingolimod-phosphate concentrations in case and control groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Multiple sclerosis (MS) patients attending out-patient neurological consultations in Caen University Hospital, with a relapsing-remitting disease course, and prescribed fingolimod as a disease-modifying drug for MS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Nguyen, MSc | Contact | +33(0)231065127 | nguyen-s@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gilles Defer, MD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Recruiting | Caen | 14000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011110 | Polymorphism, Genetic |
| ID | Term |
|---|---|
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood
| Measurement of fingolimod and fingolimod-phosphate concentrations | Diagnostic Test | Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time |
|
Trough concentration of fingolimod-phosphate in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS) |
| At inclusion |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |