A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Hospitalier Universitaire de Nice
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients enrolled in TOPIC study and extension of TOPIC study and currently treated in French extension of TOPIC study who did not convert into MS.
A baseline MRI scan (performed less than 2 months before baseline Visit ) confirming that patient is still in CIS status.
You may not be if
Contraindication for MRI,
Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease or procedure/medication making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study
Patients with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymphoproliferative disease, or any patient who has received lymphoid irradiation
Known history of active tuberculosis not adequately treated
Persistent significant or severe infection
History of drug or alcohol abuse
Patients must not have used Adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to inclusion
Prior use within 4 weeks before inclusion or concomitant use of cholestyramine
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate
Prior or concomitant use of interferons, cytokine therapy, glatiramer acetate or intravenous immunoglobulins
Prior or concomitant use of natalizumab (Tysabri®)
Pregnant or breast-feeding women
Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
Women wishing to become pregnant during the course of the trial
Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
Human immunodeficiency virus (HIV) positive patient
Persisting elevations (confirmed by retest) of serum amylase or lipase greater than 2-fold the upper limit of normal
Known history of chronic pancreatic disease or pancreatitis
Liver function impairment or persisting elevations (confirmed by retest) of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal
Known history of active hepatitis
Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin \< 3.0 g/dL
Moderate to severe impairment of renal function, as shown by serum creatinine \> 133 μmol/L (or \> 1.5 mg/dL)
Clareo Health | A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
