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
Study Type
OBSERVATIONAL
Enrollment
65
One blood tube will be taken for genetic testing
Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time
Caen University Hospital
Caen, France
RECRUITINGCYP4F2 polymorphism frequency in case and control groups
Proportion of CYP4F2 polymorphism in case and control groups
Time frame: At inclusion
Fingolimod concentrations in case and control groups
Trough concentration of fingolimod in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS)
Time frame: At inclusion
Fingolimod-phosphate concentrations in case and control groups
Trough concentration of fingolimod-phosphate in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS)
Time frame: At inclusion
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