Multiple Sclerosis
Conditions
Interventions
Trade Name: Aubagio
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
MS Centrum, Department of Neurology, Sshlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with relapsing form of MS, treated with teriflunomide for a minimum of 6 months • Age 18-65 • Patients having signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients treated with other enzyme inducing treatments • Patients with a disease with potential to affect the absorption, metabolization or elimination of teriflunomide • Patients with other CNS disease • Patients treated with other immunosuppressive or immune modulating treatments. If high dose steroids has been given, visit number 2 will be performed 30 days after the last dose of steroids. • Patients with increased risk of bleeding due to disturbances in coagulation or treatment with anticoagulant treatment. • Patient with an active relapse with a debut of less than 30 days from visit 2 • Women of child-bearing potential, not using reliable contraception • Pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with teriflunomide 14 mg daily.;Secondary Objective: • To determine and quantify transportation of teriflunomide over the blood brain barrier • To determine the concentration of teriflunomide in CSF and fluctuations of the teriflunomide concentration during the course of the day • To determine if the teriflunomide concentration is affected by the function of the blood brain barrier • To investigate if there are other factors (for example age, disease duration, gender, clinical and radiological activity and severity) affecting the concentration of teriflunomide in CSF • To investigate if specified biomarkers for neurodegeneration and inflammatory activity (NFL, GFAP, CHI3L1, and CXCL13) is affected by the concentration of teriflunomide ;Primary end point(s): Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with teriflunomide 14 mg daily.;Timepoint(s) of evaluation of this end point: At visit 2, four weeks from screening | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine and quantify transportation of teriflunomide over the blood brain barrier • To determine the concentration of teriflunomide in CSF and fluctuations of the teriflunomide concentration during the course of the day • To determine if the teriflunomide concentration is affected by the function of the blood brain barrier • To investigate if there are other factors (for example age, disease duration, gender, clinical and radiological activity and severity) affecting the concentration of teriflunomide in CSF • To investigate if specified biomarkers for neurodegeneration and inflammatory activity (NFL, GFAP, CHI3L1, and CXCL13) is affected by the concentration of teriflunomide ;Timepoint(s) of evaluation of this end point: At visit 2, four weeks from screening | — |
Countries
Sweden
Contacts
Public ContactClinical trial unit
MS Centrum, Department of Neurology, Sshlgrenska University Hospital
Outcome results
None listed