Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta (TERACLES)

May 30, 2014 updated by: Sanofi

A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).

The secondary objectives were:

  • Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:

    • Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
    • Disability progression
    • Burden of disease and disease progression as measured by brain MRI
  • Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
  • Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
  • Assess associations between variations in genes and clinical outcomes (safety and efficacy)
  • Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
  • Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study period per patient was expected to be between 56 and 160 weeks depending on when the patient was randomized and this included the following:

  • a screening period up to 4 weeks,
  • a treatment period expected to be between 48 and 152 weeks,
  • 4-week post rapid elimination follow-up period.

Patients were to continue on treatment until a fixed common end date which was approximately 48 weeks after randomization of the last patient.

For those patients who completed the treatment period, a long term extension study of approximately 1 year (including teriflunomide alone) was initially planned to be proposed.

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Argentina, Argentina, 1426
        • Investigational Site Number 032002
      • Buenos Aires, Argentina
        • Investigational Site Number 032003
      • Caba, Argentina
        • Investigational Site Number 032004
  • Australia
      • Bedford Park, Australia, 5042
        • Investigational Site Number 036008
      • Chatswood, Australia, 2067
        • Investigational Site Number 036005
      • Heidelberg West, Australia, 3081
        • Investigational Site Number 036001
      • Kogarah, Australia, 2217
        • Investigational Site Number 036004
      • New Lambton, Australia, 2305
        • Investigational Site Number 036010
  • Austria
      • Graz, Austria, 8036
        • Investigational Site Number 040001
      • Linz, Austria, 4020
        • Investigational Site Number 040004
  • Belgium
      • Charleroi, Belgium, 6000
        • Investigational Site Number 056005
      • Gent, Belgium, 9000
        • Investigational Site Number 056004
      • Hasselt, Belgium, B-3590
        • Investigational Site Number 056003
      • La Louvière, Belgium, 7100
        • Investigational Site Number 056006
      • Leuven, Belgium, 3000
        • Investigational Site Number 056002
      • Sijsele-Damme, Belgium, 8340
        • Investigational Site Number 056001
      • Wilrijk, Belgium, 2610
        • Investigational Site Number 056007
  • Brazil
      • Joinville, Brazil, 89202-165
        • Investigational Site Number 076009
      • Passo Fundo, Brazil, 99010-180
        • Investigational Site Number 076012
      • Porto Alegre, Brazil, 90020-090
        • Investigational Site Number 076003
      • Sao Paulo, Brazil, 04024-002
        • Investigational Site Number 076007
      • Sao Paulo, Brazil, 08270-070
        • Investigational Site Number 076013
  • Canada
      • Calgary, Canada, T2N 2T9
        • Investigational Site Number 124005
      • Edmonton, Canada, T6G 2G3
        • Investigational Site Number 124004
      • Gatineau, Canada, J9J 0A5
        • Investigational Site Number 124003
      • Kingston, Canada, K7L 2V7
        • Investigational Site Number 124006
      • Montreal, Canada, H3A 2B4
        • Investigational Site Number 124007
      • Ottawa, Canada, K1H 8L6
        • Investigational Site Number 124008
      • Regina, Canada, S4T 1A5
        • Investigational Site Number 124002
      • Sherbrooke, Canada, J1H 5N4
        • Investigational Site Number 124001
      • Winnipeg, Canada, R3A 1R9
        • Investigational Site Number 124009
  • Chile
      • Santiago, Chile, 7500710
        • Investigational Site Number 152003
      • Santiago, Chile, 838-0456
        • Investigational Site Number 152004
      • Viña Del Mar, Chile, 2570017
        • Investigational Site Number 152005
  • Colombia
      • Barranquilla, Colombia
        • Investigational Site Number 170001
      • Bogota, Colombia
        • Investigational Site Number 170005
      • Bogota, Colombia
        • Investigational Site Number 170007
      • Medellin, Colombia
        • Investigational Site Number 170009
  • Denmark
      • Aarhus C, Denmark, 8000
        • Investigational Site Number 208002
  • Estonia
      • Tallinn, Estonia, 10617
        • Investigational Site Number 233002
      • Tartu, Estonia, 50406
        • Investigational Site Number 233001
  • Finland
      • Helsinki, Finland, 00100
        • Investigational Site Number 246003
      • Hyvinkää, Finland, 05800
        • Investigational Site Number 246006
      • Oulu, Finland, 90220
        • Investigational Site Number 246004
      • Pori, Finland, 28100
        • Investigational Site Number 246002
      • Turku, Finland, 20100
        • Investigational Site Number 246001
  • France
      • Besancon, France, 25030
        • Investigational Site Number 250003
      • Clermont Ferrand Cedex 1, France, 63003
        • Investigational Site Number 250010
      • Lyon Cedex 03, France, 69394
        • Investigational Site Number 250002
      • Montpellier Cedex 5, France, 34000
        • Investigational Site Number 250004
      • Nancy Cedex, France, 54036
        • Investigational Site Number 250001
      • Nantes Cedex 01, France, 44093
        • Investigational Site Number 250006
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Investigational Site Number 276009
      • Bamberg, Germany, 96047
        • Investigational Site Number 276020
      • Bayreuth, Germany, 95445
        • Investigational Site Number 276003
      • Berlin, Germany, 10117
        • Investigational Site Number 276015
      • Berlin, Germany, 10713
        • Investigational Site Number 276016
      • Berlin, Germany, 12099
        • Investigational Site Number 276021
      • Bonn, Germany, 53105
        • Investigational Site Number 276012
      • Dresden, Germany, 01307
        • Investigational Site Number 276005
      • Düsseldorf, Germany, 40211
        • Investigational Site Number 276032
      • Erbach, Germany, 64711
        • Investigational Site Number 276018
      • Erlangen, Germany, 91054
        • Investigational Site Number 276004
      • Freiburg, Germany, 79098
        • Investigational Site Number 276028
      • Gießen, Germany, 35385
        • Investigational Site Number 276006
      • Hamburg, Germany, 20249
        • Investigational Site Number 276010
      • Hennigsdorf, Germany, 16761
        • Investigational Site Number 276022
      • Kassel, Germany, 34121
        • Investigational Site Number 276024
      • Leipzig, Germany, 04103
        • Investigational Site Number 276001
      • Mainz, Germany, 55131
        • Investigational Site Number 276013
      • Minden, Germany, 32429
        • Investigational Site Number 276023
      • Münster, Germany, 48149
        • Investigational Site Number 276002
      • Rostock, Germany, 18055
        • Investigational Site Number 276031
      • Wiesbaden, Germany, 65191
        • Investigational Site Number 276008
      • Wuppertal, Germany, 42283
        • Investigational Site Number 276026
  • Greece
      • Athens, Greece, 11527
        • Investigational Site Number 300002
      • Athens, Greece, 11535
        • Investigational Site Number 300001
      • Heraklion, Greece, 71110
        • Investigational Site Number 300003
      • Thessaloniki, Greece, 57010
        • Investigational Site Number 300006
  • Hungary
      • Budapest, Hungary, 1106
        • Investigational Site Number 348002
      • Budapest, Hungary, 1145
        • Investigational Site Number 348006
      • Budapest, Hungary, 1204
        • Investigational Site Number 348010
      • Eger, Hungary, 3300
        • Investigational Site Number 348009
      • Esztergom, Hungary, 2500
        • Investigational Site Number 348003
      • Szeged, Hungary, 6720
        • Investigational Site Number 348001
      • Szekesfehervar, Hungary, 8000
        • Investigational Site Number 348005
      • Zalaegerszeg, Hungary, 8900
        • Investigational Site Number 348007
  • Italy
      • Catania, Italy, 95123
        • Investigational Site Number 380009
      • Cefalù, Italy, 90015
        • Investigational Site Number 380002
      • Fidenza, Italy, 43036
        • Investigational Site Number 380003
      • Gallarate, Italy, 21013
        • Investigational Site Number 380004
      • Montichiari, Italy, 25012
        • Investigational Site Number 380012
      • Napoli, Italy, 80131
        • Investigational Site Number 380011
      • Napoli, Italy, 80131
        • Investigational Site Number 380010
      • Padova, Italy, 35128
        • Investigational Site Number 380006
      • Roma, Italy, 00133
        • Investigational Site Number 380005
      • Roma, Italy, 00161
        • Investigational Site Number 380008
      • Verona, Italy, 37134
        • Investigational Site Number 380014
  • Korea, Republic of
      • Goyang-Si, Korea, Republic of, 410-760
        • Investigational Site Number 410002
      • Seoul, Korea, Republic of, 136-705
        • Investigational Site Number 410001
      • Seoul, Korea, Republic of, 110-744
        • Investigational Site Number 410004
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Investigational Site Number 440002
      • Klaipeda, Lithuania, LT-92288
        • Investigational Site Number 440004
      • Siauliai, Lithuania, LT-76231
        • Investigational Site Number 440003
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Investigational Site Number 528001
      • Nieuwegein, Netherlands, 3435 CM
        • Investigational Site Number 528005
      • Sittard-Geleen, Netherlands, 6162 BG
        • Investigational Site Number 528002
      • Venray, Netherlands, 5801 CE
        • Investigational Site Number 528006
  • Norway
      • Tønsberg, Norway, 3116
        • Investigational Site Number 578002
  • Portugal
      • Amadora, Portugal, 2720-276
        • Investigational Site Number 620001
      • Coimbra, Portugal, 3000-075
        • Investigational Site Number 620002
      • Coimbra, Portugal, 3041-801
        • Investigational Site Number 620004
      • Setubal, Portugal, 2910-446
        • Investigational Site Number 620003
  • Russian Federation
      • Kaluga, Russian Federation, 248007
        • Investigational Site Number 643012
      • Kazan, Russian Federation, 420021
        • Investigational Site Number 643007
      • Kemerovo, Russian Federation, 650066
        • Investigational Site Number 643001
      • Moscow, Russian Federation, 129110
        • Investigational Site Number 643013
      • Nizhny Novgorod, Russian Federation, 603126
        • Investigational Site Number 643004
      • Nizhny Novgorod, Russian Federation, 603076
        • Investigational Site Number 643006
      • Novosibirsk, Russian Federation, 630007
        • Investigational Site Number 643015
      • Rostov-On-Don, Russian Federation, 344015
        • Investigational Site Number 643010
      • Rostov-On-Don, Russian Federation, 344022
        • Investigational Site Number 643009
      • Samara, Russian Federation, 443095
        • Investigational Site Number 643016
      • Smolensk, Russian Federation, 214019
        • Investigational Site Number 643005
      • St-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643003
      • St-Petersburg, Russian Federation, 194044
        • Investigational Site Number 643011
      • St-Petersburg, Russian Federation, 194291
        • Investigational Site Number 643018
      • St-Petersburg, Russian Federation, 197089
        • Investigational Site Number 643017
      • St-Petersburg, Russian Federation, 197376
        • Investigational Site Number 643002
      • Yaroslavl, Russian Federation, 150030
        • Investigational Site Number 643014
  • Slovakia
      • Martin, Slovakia, 03659
        • Investigational Site Number 703002
      • Trnava, Slovakia, 91775
        • Investigational Site Number 703001
  • Spain
      • Barcelona, Spain, 08035
        • Investigational Site Number 724001
      • Barcelona, Spain, 08036
        • Investigational Site Number 724002
      • Córdoba, Spain, 14004
        • Investigational Site Number 724009
      • Girona, Spain, 17007
        • Investigational Site Number 724003
      • Madrid, Spain, 28005
        • Investigational Site Number 724004
      • Madrid, Spain, 28040
        • Investigational Site Number 724005
      • Murcia, Spain, 30120
        • Investigational Site Number 724007
      • Sevilla, Spain, 41008
        • Investigational Site Number 724008
  • Sweden
      • Göteborg, Sweden, 413 45
        • Investigational Site Number 752004
      • Stockholm, Sweden, 171 76
        • Investigational Site Number 752001
      • Stockholm, Sweden, 14186
        • Investigational Site Number 752003
  • Tunisia
      • Manouba, Tunisia, 2010
        • Investigational Site Number 788002
      • Monastir, Tunisia, 5000
        • Investigational Site Number 788005
      • Sfax, Tunisia, 3029
        • Investigational Site Number 788004
      • Tunis, Tunisia, 1008
        • Investigational Site Number 788006
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Investigational Site Number 826008
      • Leeds, United Kingdom, LS1 3EX
        • Investigational Site Number 826005
      • Liverpool, United Kingdom, L9 7LJ
        • Investigational Site Number 826006
      • London, United Kingdom, SW17 0QT
        • Investigational Site Number 826003
      • Plymouth, United Kingdom, PL6 8BX
        • Investigational Site Number 826004
      • Salford, United Kingdom, M6 8HD
        • Investigational Site Number 826001
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • Investigational Site Number 840049
    • Alaska
      • Cordova, Alaska, United States, 38018
        • Investigational Site Number 840005
    • Arizona
      • Phoenix, Arizona, United States, 85060
        • Investigational Site Number 840003
    • California
      • Oceanside, California, United States, 92056
        • Investigational Site Number 840011
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Investigational Site Number 840036
    • Florida
      • Maitland, Florida, United States, 32761
        • Investigational Site Number 840012
      • Ormond Beach, Florida, United States, 32174
        • Investigational Site Number 840013
      • Pompano Beach, Florida, United States, 33060
        • Investigational Site Number 840055
      • St. Petersburg, Florida, United States, 33713
        • Investigational Site Number 840021
      • Tampa, Florida, United States, 33609-4052
        • Investigational Site Number 840004
      • Tampa, Florida, United States, 33612
        • Investigational Site Number 840047
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Investigational Site Number 840034
      • Elk Grove Village, Illinois, United States, 60007
        • Investigational Site Number 840037
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Investigational Site Number 840033
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Investigational Site Number 840028
      • Baltimore, Maryland, United States, 21201
        • Investigational Site Number 840041
    • Michigan
      • Clinton Township, Michigan, United States, 48035
        • Investigational Site Number 840016
    • Missouri
      • St Louis, Missouri, United States, 63104
        • Investigational Site Number 840031
      • St Louis, Missouri, United States, 63110
        • Investigational Site Number 840030
    • Montana
      • Missoula, Montana, United States, 59802
        • Investigational Site Number 840009
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Investigational Site Number 840023
    • New York
      • New York, New York, United States, 10029
        • Investigational Site Number 840015
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Investigational Site Number 840027
    • North Dakota
      • Bismark, North Dakota, United States, 58501
        • Investigational Site Number 840006
      • Fargo, North Dakota, United States, 58103
        • Investigational Site Number 840007
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Investigational Site Number 840046
      • Toledo, Ohio, United States, 43699
        • Investigational Site Number 840017
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Investigational Site Number 840043
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Investigational Site Number 840002
    • Texas
      • Round Rock, Texas, United States, 78681
        • Investigational Site Number 840040
      • San Antonio, Texas, United States, 78231
        • Investigational Site Number 840020
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Investigational Site Number 840032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • Patient with relapsing forms of MS treated with IFN-beta
  • Stable dose of IFN-beta (approved brand) for at least 6 months prior to randomization
  • Disease activity in the 12 months prior to randomization and after first 3 months of IFN-beta treatment (defined by at least 1 relapse supported by EDSS or equivalent neurological examination, or, at least 1 brain or spinal cord MRI with at least one T1 gadolinium enhancing lesion)

Exclusion criteria:

  • McDonald criteria for MS diagnosis not met at time of screening visit
  • EDSS score greater than (>) 5.5 at randomization visit
  • A relapse within 30 days prior randomization
  • Persistent significant or severe infection
  • Patients must not have used adrenocorticotrophic hormone or systemic corticosteroids for 2 weeks prior to randomization
  • Prior or concomitant use of cytokine therapy (except baseline interferons), glatiramer acetate or intravenous immunoglobulins in the 3 months preceding randomization
  • Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2 times the upper limit of normal range (ULN)
  • Active hepatitis or hepatobiliary disease or known history of severe hepatitis
  • Pregnant or breast-feeding women or those who were planning to become pregnant during the study
  • Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
  • Human Immunodeficiency Virus (HIV) positive
  • Known history of active tuberculosis not adequately treated
  • Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone
  • Prior use within 6 months preceding randomization or concomitant use of natalizumab, or any other immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, mycophenolate, or fingolimod

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Teriflunomide 7 mg + IFN-beta
Teriflunomide 7 milligram (mg) once a day concomitantly with IFN-beta therapy.
Drug: Teriflunomide

Film-coated tablet

Oral administration

Other Names:
  • HMR1726
Drug: Interferon-beta (IFN-beta)

Any of the IFN-beta which are approved for marketed use in the country where the patient is enrolled.

Administration according to the package insert.
EXPERIMENTAL: Teriflunomide 14 mg + IFN-beta
Teriflunomide 14 mg once a day concomitantly with IFN-beta therapy.
Drug: Teriflunomide

Film-coated tablet

Oral administration

Other Names:
  • HMR1726
Drug: Interferon-beta (IFN-beta)

Any of the IFN-beta which are approved for marketed use in the country where the patient is enrolled.

Administration according to the package insert.
PLACEBO_COMPARATOR: Placebo + IFN-beta
Placebo (for teriflunomide) once a day concomitantly with IFN-beta therapy.
Drug: Placebo (for teriflunomide)

Film-coated tablet

Oral administration

Drug: Interferon-beta (IFN-beta)

Any of the IFN-beta which are approved for marketed use in the country where the patient is enrolled.

Administration according to the package insert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Relapse Rate (ARR) (Poisson Regression Estimates)
Time Frame: Up to a maximum of 108 weeks depending on time of enrollment
ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and IFN-beta dose stratum, and number of relapses in the year prior to randomization as covariates).
Up to a maximum of 108 weeks depending on time of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)
Time Frame: Up to a maximum of 108 weeks depending on time of enrollment
Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-beta dose stratum and baseline number of Gd-enhancing T1-lesions as covariates).
Up to a maximum of 108 weeks depending on time of enrollment
Time to 12-Week Sustained Disability Progression
Time Frame: Up to a maximum of 108 weeks depending on time of enrollment
The 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. Probability of disability progression was to be estimated using Kaplan-Meier method.
Up to a maximum of 108 weeks depending on time of enrollment
Brain MRI Assessment: Volume of Gd-enhancing T1-lesions Per MRI Scan
Time Frame: Up to a maximum of 108 weeks depending on time of enrollment
Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period.
Up to a maximum of 108 weeks depending on time of enrollment
Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24
Time Frame: Baseline, Week 24
The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, region, IFN-beta dose stratum, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.
Baseline, Week 24
Time to Relapse: Kaplan-Meier Estimates of the Probability of no Relapse at Week 24, 48, and 72
Time Frame: Up to a maximum of 108 weeks depending on time of enrollment
Probability of no relapse at 24, 48 and 72 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse. Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time <=t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.
Up to a maximum of 108 weeks depending on time of enrollment
Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24
Time Frame: Baseline, Week 24
FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.
Baseline, Week 24
Change From Baseline in Short Form Generic Health Survey - 36 Items, Version 2 (SF-36v2) Summary Scores at Week 24
Time Frame: Baseline, Week 24
SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.
Baseline, Week 24
Resource Utilization When Relapse
Time Frame: Up to a maximum of 108 weeks depending on time of enrollment
Resource utilization each time a participant experiences an MS relapse, specifically the number of hospitalizations, the number of over night spent in the hospital and number of intensive care admissions if hospitalized were to be reported.
Up to a maximum of 108 weeks depending on time of enrollment
Overview of Adverse Events (AEs)
Time Frame: First study drug intake up to 28 days after last study drug intake, for up to 112 weeks
AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
First study drug intake up to 28 days after last study drug intake, for up to 112 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Time Frame: First study drug intake up to 28 days after last study drug intake, for up to 112 weeks
PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows: Alanine Aminotransferase (ALT) >3, 5 or 10 Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) >3, 5 or 10 ULN; Alkaline Phosphatase >1.5 ULN; Total Bilirubin (TB) >1.5 ULN; and ALT >3 ULN and TB >2 ULN.
First study drug intake up to 28 days after last study drug intake, for up to 112 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (ESTIMATE)

December 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6058
  • 2010-023172-12 (EUDRACT_NUMBER)
  • U1111-1115-2414 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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