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Completed

NCT Number: NCT01487096

Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

* To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures. * To investigate the pharmacokinetic and pharmacodynamic relationships.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Canada, Toronto, Ontario

Loading trial locations.

About this study

The total duration of the study period per participants was 46 weeks comprising 3 periods:

  • a 4-week screening period,
  • a 36-week double-blind treatment period,
  • a 6-week post-treatment follow-up period.

Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically confirmed multiple sclerosis [MS];
  • Expanded Disability Status Scale [EDSS] score less or equal to 6;
  • Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
  • Screening magnetic resonance imaging [MRI] scan fulfilling the criteria for a diagnosis of MS.

Exclusion criteria

  • Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
  • Pregnant or nursing woman;
  • Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
  • Prior treatment with interferon [IFN], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
  • Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
  • Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Teriflunomide

Drug

film-coated tablet

oral administration

Other names: HMR1726

Placebo (placebo for teriflunomide)

Drug

film-coated tablet

oral administration

Primary outcomes

  1. MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis)

    Time frame: 36 weeks

    The number of unique active lesions per scan was calculated by dividing the sum of unique newly active lesions and unique persistently active lesions observed on treatment by the number of scans performed on treatment.

    Unique newly active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan but not in the previous scan and, that had not been classified as unique newly active in any previous scan.

    Unique persistently active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan and also in the previous scan.

  2. Overview of Adverse Events [AE]

    Time frame: from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first

    AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

Secondary outcomes

  1. MRI assessment: number of T1-enhancing lesions per scan

    Time frame: 36 weeks

    T1-enhancing lesions included:

    • Newly enhancing T1 lesions: lesions enhanced on the current T1 scan but not enhanced in any previous T1 scan.
    • Persistently enhancing T1 lesions: lesions enhanced on the current T1 scan and enhanced on the previous T1 scan.

  2. MRI assessment: number of T2-lesions per scan

    Time frame: 36 weeks

    T2-lesions included:

    • New T2-lesions: lesions that appeared on the current T2 scan but were not visible on any previous T2 scans.
    • Newly enlarging T2-lesions: lesions that appeared enlarged on the current T2 scan but were stable on the previous T2 scan.
    • Persistently enlarging T2-lesions: further enlarged lesions on the current T2 scan categorized as new or enlarging on the previous T2 scan.

  3. MRI assessment: Number of participants with no new lesions

    Time frame: 36 weeks

    New lesions included new T2 lesions, new enhanced T1 lesions and unique newly active lesions.

  4. MRI assessment: Change from baseline in T2 burden of disease

    Time frame: 36 weeks

    T2 burden of disease was defined as the total volume of all T2 lesions.

  5. Number of participants with progression on Expanded Disability Status Scale [EDSS]

    Time frame: 36 weeks

    EDSS is an ordinal scale in half-point increments that qualifies disability in patients with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.

    EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).

    Progression was defined as an increase in EDSS score by at least 1-point when baseline EDSS score ≤5.5 or an increase in EDSS score by at least 0.5-point in when baseline EDSS score >5.5.

  6. Number of participants with MS relapse confirmed by Scripps Neurological Rating Scale [NRS] and EDSS scores.

    Time frame: 36 weeks

    A relapse was defined as the appearance, reappearance or worsening of a symptom attributable to MS. The change had to persist for at least 48 hours in the absence of fever and be preceded by stability or improvement for at least 30 days. Relapses were to be confirmed by Scripps NRS and EDSS scores.

    NRS is a scale that qualifies the degree of impairment from a neurological exam of the following systems: mentation and mood, cranial nerves, motor nerves, deep tendon reflexes, sensory nerves, cerebellum, gait/trunk/balance, bladder/bowel/sexual dysfunction.

    NRS score ranges from 0 to 100 (lower degree of impairment).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Dec 7, 2011
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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