Trial record 1 of 1 for:    sanofi teracles
Previous Study | Return to List | Next Study

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

This study has been terminated.
(Sponsor decision to prematurely stop the study, not linked to any safety concern.)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01252355
First received: November 30, 2010
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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)

Condition Intervention Phase
Multiple Sclerosis Relapse
Drug: Teriflunomide
Drug: Placebo (for teriflunomide)
Drug: Interferon-beta (IFN-beta)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Annualized Relapse Rate (ARR) (Poisson Regression Estimates) [ Time Frame: Up to a maximum of 108 weeks depending on time of enrollment ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • Time to 12-Week Sustained Disability Progression [ Time Frame: Up to a maximum of 108 weeks depending on time of enrollment ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.

  • 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 ] [ Designated as safety issue: No ]
    SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.

  • Resource Utilization When Relapse [ Time Frame: Up to a maximum of 108 weeks depending on time of enrollment ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 534
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252355

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01252355     History of Changes
Other Study ID Numbers: EFC6058, 2010-023172-12, U1111-1115-2414
Study First Received: November 30, 2010
Results First Received: April 23, 2014
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferons
Interferon-beta
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014