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

Multiple Sclerosis Clinical Trial

— TERICIS  

Official title:

A National, Multi-center 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587195
• Other study ID #: 15-PP-06
• Status: Completed
• Phase: Phase 3
• Start date: December 18, 2015
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

National, multicenter study:

The study consists of 3 periods:

1. A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria.

2. Treatment period with timed evaluations

3. Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and accelerated elimination procedure. All patients who discontinue the study drug and according to investgator's decision, will perform the accelerated elimination procedure and the post- accelerated elimination visits (at 2 and 4 weeks after the end of treatment (EOT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Teriflunomide

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	CHU de Lille	Lille
France	CHU de Montpellier	Montpellier
France	CHU de Nice	Nice
France	CHU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event reporting	evaluation of safety and tolerability of teriflunomide 14mg per day	throughout study completion an average of 6 months
Primary	Adverse Events That Are Related to Treatment		throughout study completion an average of 6 months
Secondary	Conversion based on MRI	Conversion to definite MS based on MRI data as defined by the demonstration of dissemination of MRI lesions in time (based on the 2010 revised McDonald criteria) within 3 years	throughout study completion an average of 6 months
Secondary	Conversion based on Clinical evaluation	Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year	throughout study completion an average of 6 months
Secondary	Conversion based on annualized relapse rate (ARR)	Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year	throughout study completion an average of 6 months
Secondary	volume of abnormal brain tissue on MRI		3 years
Secondary	Disability progression defined as a 1.0-point increase in EDSS score	to disability progression (12 weeks), defined as a 1.0-point increase in EDSS score (or 0.5-point increase for baseline EDSS >5.5) confirmed after at least 12 weeks	confirmed after at least 12 weeks
Secondary	Proportion of disability-free subjects as assessed by the EDSS	Proportion of disability-free subjects as assessed by the EDSS	throughout study completion an average of 1 year
Secondary	Fatigue Impact Scale	Patient-reported fatigue based on the Fatigue Impact Scale	throughout study completion an average of 1 year
Secondary	Quality of life using SF-36		throughout study completion an average of 1 year