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

NCT02587195 | Completed Phase 3

• 1 other identifier: 15-PP-06
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

National, multicenter study: The study consists of 3 periods:

1. 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. 2.Treatment period with timed evaluations
3. 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).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Adverse event reporting

  evaluation of safety and tolerability of teriflunomide 14mg per day

  throughout study completion an average of 6 months

• Adverse Events That Are Related to Treatment

  throughout study completion an average of 6 months

Secondary Outcomes (8)

• Conversion based on MRI

  throughout study completion an average of 6 months

• Conversion based on Clinical evaluation

  throughout study completion an average of 6 months

• Conversion based on annualized relapse rate (ARR)

  throughout study completion an average of 6 months

• volume of abnormal brain tissue on MRI

  3 years

• Disability progression defined as a 1.0-point increase in EDSS score

  confirmed after at least 12 weeks

Study Arms (1)

Teriflunomide

EXPERIMENTAL

Teriflunomide 14 mg Once Daily

Drug: Teriflunomide

Interventions

Teriflunomide DRUG

Teriflunomide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 qualify 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (5)

CHU de Besançon

Besançon, 25030, France

Location

CHU de Lille

Lille, 59037, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nice

Nice, 06000, France

Location

CHU de Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 27, 2015
• Study Start: December 18, 2015
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

FR (5)