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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 (TERICIS)

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ClinicalTrials.gov Identifier: NCT02587195
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Teriflunomide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 18, 2015
Estimated Primary Completion Date : January 18, 2019
Estimated Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Teriflunomide
Teriflunomide 14 mg Once Daily
Drug: Teriflunomide



Primary Outcome Measures :
  1. Adverse event reporting [ Time Frame: throughout study completion an average of 6 months ]
    evaluation of safety and tolerability of teriflunomide 14mg per day

  2. Adverse Events That Are Related to Treatment [ Time Frame: throughout study completion an average of 6 months ]

Secondary Outcome Measures :
  1. Conversion based on MRI [ Time Frame: throughout study completion an average of 6 months ]
    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

  2. Conversion based on Clinical evaluation [ Time Frame: throughout study completion an average of 6 months ]
    Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year

  3. Conversion based on annualized relapse rate (ARR) [ Time Frame: throughout study completion an average of 6 months ]
    Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year

  4. volume of abnormal brain tissue on MRI [ Time Frame: 3 years ]
  5. Disability progression defined as a 1.0-point increase in EDSS score [ Time Frame: confirmed after at least 12 weeks ]
    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

  6. Proportion of disability-free subjects as assessed by the EDSS [ Time Frame: throughout study completion an average of 1 year ]
    Proportion of disability-free subjects as assessed by the EDSS

  7. Fatigue Impact Scale [ Time Frame: throughout study completion an average of 1 year ]
    Patient-reported fatigue based on the Fatigue Impact Scale

  8. Quality of life using SF-36 [ Time Frame: throughout study completion an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587195


Locations
France
CHU de Besançon
Besançon, France, 25030
CHU de Lille
Lille, France, 59037
CHU de Montpellier
Montpellier, France, 34295
CHU de Nice
Nice, France, 06000
CHU de Strasbourg
Strasbourg, France, 67098
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02587195     History of Changes
Other Study ID Numbers: 15-PP-06
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Centre Hospitalier Universitaire de Nice:
Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases