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

Primary Purpose

Multiple Sclerosis Relapse

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Teriflunomide
Placebo (for teriflunomide)
Interferon-beta (IFN-beta)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis Relapse

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840049
  • Investigational Site Number 840005
  • Investigational Site Number 840003
  • Investigational Site Number 840011
  • Investigational Site Number 840036
  • Investigational Site Number 840012
  • Investigational Site Number 840013
  • Investigational Site Number 840055
  • Investigational Site Number 840021
  • Investigational Site Number 840004
  • Investigational Site Number 840047
  • Investigational Site Number 840034
  • Investigational Site Number 840037
  • Investigational Site Number 840033
  • Investigational Site Number 840041
  • Investigational Site Number 840028
  • Investigational Site Number 840016
  • Investigational Site Number 840031
  • Investigational Site Number 840030
  • Investigational Site Number 840009
  • Investigational Site Number 840023
  • Investigational Site Number 840015
  • Investigational Site Number 840027
  • Investigational Site Number 840006
  • Investigational Site Number 840007
  • Investigational Site Number 840046
  • Investigational Site Number 840017
  • Investigational Site Number 840043
  • Investigational Site Number 840002
  • Investigational Site Number 840040
  • Investigational Site Number 840020
  • Investigational Site Number 840032
  • Investigational Site Number 032002
  • Investigational Site Number 032003
  • Investigational Site Number 032004
  • Investigational Site Number 036008
  • Investigational Site Number 036005
  • Investigational Site Number 036001
  • Investigational Site Number 036004
  • Investigational Site Number 036010
  • Investigational Site Number 040001
  • Investigational Site Number 040004
  • Investigational Site Number 056005
  • Investigational Site Number 056004
  • Investigational Site Number 056003
  • Investigational Site Number 056006
  • Investigational Site Number 056002
  • Investigational Site Number 056001
  • Investigational Site Number 056007
  • Investigational Site Number 076009
  • Investigational Site Number 076012
  • Investigational Site Number 076003
  • Investigational Site Number 076007
  • Investigational Site Number 076013
  • Investigational Site Number 124005
  • Investigational Site Number 124004
  • Investigational Site Number 124003
  • Investigational Site Number 124006
  • Investigational Site Number 124007
  • Investigational Site Number 124008
  • Investigational Site Number 124002
  • Investigational Site Number 124001
  • Investigational Site Number 124009
  • Investigational Site Number 152003
  • Investigational Site Number 152004
  • Investigational Site Number 152005
  • Investigational Site Number 170001
  • Investigational Site Number 170005
  • Investigational Site Number 170007
  • Investigational Site Number 170009
  • Investigational Site Number 208002
  • Investigational Site Number 233002
  • Investigational Site Number 233001
  • Investigational Site Number 246003
  • Investigational Site Number 246006
  • Investigational Site Number 246004
  • Investigational Site Number 246002
  • Investigational Site Number 246001
  • Investigational Site Number 250003
  • Investigational Site Number 250010
  • Investigational Site Number 250002
  • Investigational Site Number 250004
  • Investigational Site Number 250001
  • Investigational Site Number 250006
  • Investigational Site Number 276009
  • Investigational Site Number 276020
  • Investigational Site Number 276003
  • Investigational Site Number 276015
  • Investigational Site Number 276016
  • Investigational Site Number 276021
  • Investigational Site Number 276012
  • Investigational Site Number 276005
  • Investigational Site Number 276032
  • Investigational Site Number 276018
  • Investigational Site Number 276004
  • Investigational Site Number 276028
  • Investigational Site Number 276006
  • Investigational Site Number 276010
  • Investigational Site Number 276022
  • Investigational Site Number 276024
  • Investigational Site Number 276001
  • Investigational Site Number 276013
  • Investigational Site Number 276023
  • Investigational Site Number 276002
  • Investigational Site Number 276031
  • Investigational Site Number 276008
  • Investigational Site Number 276026
  • Investigational Site Number 300002
  • Investigational Site Number 300001
  • Investigational Site Number 300003
  • Investigational Site Number 300006
  • Investigational Site Number 348002
  • Investigational Site Number 348006
  • Investigational Site Number 348010
  • Investigational Site Number 348009
  • Investigational Site Number 348003
  • Investigational Site Number 348001
  • Investigational Site Number 348005
  • Investigational Site Number 348007
  • Investigational Site Number 380009
  • Investigational Site Number 380002
  • Investigational Site Number 380003
  • Investigational Site Number 380004
  • Investigational Site Number 380012
  • Investigational Site Number 380010
  • Investigational Site Number 380011
  • Investigational Site Number 380006
  • Investigational Site Number 380005
  • Investigational Site Number 380008
  • Investigational Site Number 380014
  • Investigational Site Number 410002
  • Investigational Site Number 410004
  • Investigational Site Number 410001
  • Investigational Site Number 440002
  • Investigational Site Number 440004
  • Investigational Site Number 440003
  • Investigational Site Number 528001
  • Investigational Site Number 528005
  • Investigational Site Number 528002
  • Investigational Site Number 528006
  • Investigational Site Number 578002
  • Investigational Site Number 620001
  • Investigational Site Number 620002
  • Investigational Site Number 620004
  • Investigational Site Number 620003
  • Investigational Site Number 643012
  • Investigational Site Number 643007
  • Investigational Site Number 643001
  • Investigational Site Number 643013
  • Investigational Site Number 643006
  • Investigational Site Number 643004
  • Investigational Site Number 643015
  • Investigational Site Number 643010
  • Investigational Site Number 643009
  • Investigational Site Number 643016
  • Investigational Site Number 643005
  • Investigational Site Number 643011
  • Investigational Site Number 643018
  • Investigational Site Number 643003
  • Investigational Site Number 643017
  • Investigational Site Number 643002
  • Investigational Site Number 643014
  • Investigational Site Number 703002
  • Investigational Site Number 703001
  • Investigational Site Number 724001
  • Investigational Site Number 724002
  • Investigational Site Number 724009
  • Investigational Site Number 724003
  • Investigational Site Number 724004
  • Investigational Site Number 724005
  • Investigational Site Number 724007
  • Investigational Site Number 724008
  • Investigational Site Number 752004
  • Investigational Site Number 752003
  • Investigational Site Number 752001
  • Investigational Site Number 788002
  • Investigational Site Number 788005
  • Investigational Site Number 788004
  • Investigational Site Number 788006
  • Investigational Site Number 826008
  • Investigational Site Number 826005
  • Investigational Site Number 826006
  • Investigational Site Number 826003
  • Investigational Site Number 826004
  • Investigational Site Number 826001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Teriflunomide 7 mg + IFN-beta

Teriflunomide 14 mg + IFN-beta

Placebo + IFN-beta

Arm Description

Teriflunomide 7 milligram (mg) once a day concomitantly with IFN-beta therapy.

Teriflunomide 14 mg once a day concomitantly with IFN-beta therapy.

Placebo (for teriflunomide) once a day concomitantly with IFN-beta therapy.

Outcomes

Primary Outcome Measures

Annualized Relapse Rate (ARR) (Poisson Regression Estimates)
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)
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
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
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
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
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
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
SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.
Resource Utilization When Relapse
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)
AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

Full Information

First Posted
November 30, 2010
Last Updated
May 30, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01252355
Brief Title
Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
Acronym
TERACLES
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to prematurely stop the study, not linked to any safety concern.
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis Relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teriflunomide 7 mg + IFN-beta
Arm Type
Experimental
Arm Description
Teriflunomide 7 milligram (mg) once a day concomitantly with IFN-beta therapy.
Arm Title
Teriflunomide 14 mg + IFN-beta
Arm Type
Experimental
Arm Description
Teriflunomide 14 mg once a day concomitantly with IFN-beta therapy.
Arm Title
Placebo + IFN-beta
Arm Type
Placebo Comparator
Arm Description
Placebo (for teriflunomide) once a day concomitantly with IFN-beta therapy.
Intervention Type
Drug
Intervention Name(s)
Teriflunomide
Other Intervention Name(s)
HMR1726
Intervention Description
Film-coated tablet Oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo (for teriflunomide)
Intervention Description
Film-coated tablet Oral administration
Intervention Type
Drug
Intervention Name(s)
Interferon-beta (IFN-beta)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Annualized Relapse Rate (ARR) (Poisson Regression Estimates)
Description
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).
Time Frame
Up to a maximum of 108 weeks depending on time of enrollment
Secondary Outcome Measure Information:
Title
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)
Description
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 Frame
Up to a maximum of 108 weeks depending on time of enrollment
Title
Time to 12-Week Sustained Disability Progression
Description
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.
Time Frame
Up to a maximum of 108 weeks depending on time of enrollment
Title
Brain MRI Assessment: Volume of Gd-enhancing T1-lesions Per MRI Scan
Description
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.
Time Frame
Up to a maximum of 108 weeks depending on time of enrollment
Title
Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24
Description
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 Frame
Baseline, Week 24
Title
Time to Relapse: Kaplan-Meier Estimates of the Probability of no Relapse at Week 24, 48, and 72
Description
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.
Time Frame
Up to a maximum of 108 weeks depending on time of enrollment
Title
Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24
Description
FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Short Form Generic Health Survey - 36 Items, Version 2 (SF-36v2) Summary Scores at Week 24
Description
SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.
Time Frame
Baseline, Week 24
Title
Resource Utilization When Relapse
Description
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.
Time Frame
Up to a maximum of 108 weeks depending on time of enrollment
Title
Overview of Adverse Events (AEs)
Description
AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Time Frame
First study drug intake up to 28 days after last study drug intake, for up to 112 weeks
Other Pre-specified Outcome Measures:
Title
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Description
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.
Time Frame
First study drug intake up to 28 days after last study drug intake, for up to 112 weeks

10. Eligibility

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

12. IPD Sharing Statement

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

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