Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily.

• Register: EUCTR
• Last refreshed on: 12 March 2018
• Main ID: EUCTR2016-004414-10-SE
• Date of registration: 02/01/2018
• Prospective Registration: Yes
• Primary sponsor: MS Centrum, Department of Neurology, Sshlgrenska University Hospital
• Public title: Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily.
• Scientific title: Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily.
• Date of first enrolment: 23/02/2018
• Target sample size: 20
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004414-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Sweden

Contacts

• Name: Clinical trial unit
• Affiliation: MS Centrum, Department of Neurology, Sshlgrenska University Hospital

• Name: Clinical trial unit
• Affiliation: MS Centrum, Department of Neurology, Sshlgrenska University Hospital

Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Multiple Sclerosis

Intervention(s)

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 number: 14-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At visit 2, four weeks from screening

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.

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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: At visit 2, four weeks from screening

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

Secondary ID(s)

TERIFL08519

Source(s) of Monetary Support

Sanofi