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Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Teriflunomide (HMR1726)

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Oral treatment

Eligibility Criteria

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

Inclusion Criteria:

Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Placebo/Teriflunomide 7 mg

Teriflunomide 7 mg/7 mg

Placebo/Teriflunomide 14 mg

Teriflunomide 14 mg/14 mg

Arm Description

Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.

Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.

Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.

Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.

Secondary Outcome Measures

Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP

Sustained DP defined as sustained increase of at least 1 point from baseline (EFC6049) expanded disability status scale (EDSS) score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to Multiple Sclerosis [MS]). Probability of DP at 12 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. 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 to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP

Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 24 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). Probability of DP at 24 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. 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.

Percentage of Participants Free of Sustained Disability Progression (DP)

Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks and 24 weeks. EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicates worse neurological function. Percentage of participants who were considered as free of disability progression confirmed after 12 week sustained progression and 24 week sustained progression were reported. Analysis for this outcome measure was performed on combined data of EFC6049 and LTS6050 study, as pre-specified in protocol.

Annualized MS Relapse Rate (ARR): Poisson Regression Estimates

ARR was obtained from total number of confirmed relapses that occurred during treatment period divided by sum of treatment durations in LTS6050 study only. 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 EDSS score or Functional System (FS) scores. EDSS: an ordinal scale qualifies disability. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). FSS: to assess the neurological function. Total score range: 0 (normal) - 6(worse), higher scores = worse neurological function. To account for the different treatment duration 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 enrolment and baseline EDSS stratum as covariates).

Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization

BOD was assessed by cerebral MRI and defined as the total volume of all abnormal brain tissue (calculated as the sum of the total volume of T2-lesion component and T1-hypointense lesion component).

Full Information

NCT ID

NCT00803049

First Posted

December 1, 2008

Last Updated

December 5, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00803049

Brief Title

Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Official Title

Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (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 of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

Detailed Description

Participants completing the EFC6049 (HMR1726D/3001) study were given the opportunity to continue in the extension study; participants receiving teriflunomide 7 mg or 14 mg were blindly maintained on the same dose of teriflunomide. participants receiving placebo were randomized at a 1:1 ratio to teriflunomide 7 mg or 14 mg. The study period per participant was broken down as follows: Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide was commercially available in the country where participant lived, Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if participant continued on teriflunomide treatment by obtaining its commercial form after end of the study. The total duration of the extension was 292 weeks (about 6 years) from the first participant enrolled or until teriflunomide is commercially available in the country where participant lived.

6. Conditions and Keywords

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

Multiple Sclerosis

Keywords

Multiple Sclerosis, Oral treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

742 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo/Teriflunomide 7 mg

Arm Type

Experimental

Arm Description

Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.

Arm Title

Teriflunomide 7 mg/7 mg

Arm Type

Experimental

Arm Description

Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.

Arm Title

Placebo/Teriflunomide 14 mg

Arm Type

Experimental

Arm Description

Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.

Arm Title

Teriflunomide 14 mg/14 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Teriflunomide (HMR1726)

Other Intervention Name(s)

Aubagio

Intervention Description

Tablet, oral administration QD.

Primary Outcome Measure Information:

Title

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks

Secondary Outcome Measure Information:

Title

Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP

Description

Time Frame

Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)

Title

Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP

Description

Time Frame

Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)

Title

Percentage of Participants Free of Sustained Disability Progression (DP)

Description

Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks and 24 weeks. EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicates worse neurological function. Percentage of participants who were considered as free of disability progression confirmed after 12 week sustained progression and 24 week sustained progression were reported. Analysis for this outcome measure was performed on combined data of EFC6049 and LTS6050 study, as pre-specified in protocol.

Time Frame

Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks)

Title

Annualized MS Relapse Rate (ARR): Poisson Regression Estimates

Description

Time Frame

Up to 8 years since LTS6050 randomization

Title

Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization

Description

BOD was assessed by cerebral MRI and defined as the total volume of all abnormal brain tissue (calculated as the sum of the total volume of T2-lesion component and T1-hypointense lesion component).

Time Frame

Baseline, Week 192

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal. Willingness to participate in a long-term safety/efficacy trial. Exclusion Criteria: Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study. The above information is not intended to contain all considerations relevant to a participant'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 1032

City

Maitland

State/Province

Florida

ZIP/Postal Code

32761

Country

United States

Facility Name

Investigational Site Number 1038

City

Ft. Wayne

State/Province

Indiana

ZIP/Postal Code

63104

Country

United States

Facility Name

Investigational Site Number 1033

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Investigational Site Number 1037

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Investigational Site Number 1603

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Investigational Site Number 1604

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Investigational Site Number 1601

City

Wien

ZIP/Postal Code

1010

Country

Austria

Facility Name

Investigational Site Number 1602

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Investigational Site Number 1208

City

Calgary

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

Investigational Site Number 1212

City

Gatineau

ZIP/Postal Code

J9J 0A5

Country

Canada

Facility Name

Investigational Site Number 1205

City

Greenfield Park

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

Investigational Site Number 1201

City

Halifax

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Investigational Site Number 1206

City

London

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Investigational Site Number 1203

City

Montreal

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Investigational Site Number 1204

City

Ottawa

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Investigational Site Number 1202

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Investigational Site Number 1211

City

St. John'S

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

Investigational Site Number 1209

City

Toronto

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Investigational Site Number 1210

City

Vancouver

ZIP/Postal Code

V6T 2B5

Country

Canada

Facility Name

Investigational Site Number 1207

City

Winnipeg

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

Investigational Site Number 3804

City

Santiago

ZIP/Postal Code

750-0710

Country

Chile

Facility Name

Investigational Site Number 3802

City

Santiago

ZIP/Postal Code

760-0746

Country

Chile

Facility Name

Investigational Site Number 3803

City

Santiago

ZIP/Postal Code

890-0085

Country

Chile

Facility Name

Investigational Site Number 3801

City

Santiago

Country

Chile

Facility Name

Investigational Site Number 3805

City

Viña Del Mar

Country

Chile

Facility Name

Investigational Site Number 4101

City

Olomouc

ZIP/Postal Code

77520

Country

Czech Republic

Facility Name

Investigational Site Number 4801

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Investigational Site Number 4804

City

Sønderborg

ZIP/Postal Code

6400

Country

Denmark

Facility Name

Investigational Site Number 4802

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Investigational Site Number 1502

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Investigational Site Number 1501

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Investigational Site Number 2203

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Investigational Site Number 2206

City

Pori

ZIP/Postal Code

28100

Country

Finland

Facility Name

Investigational Site Number 2201

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Investigational Site Number 2202

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Investigational Site Number 2415

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Investigational Site Number 2403

City

Clermont Ferrand Cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Investigational Site Number 2408

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Investigational Site Number 2413

City

Lille Cedex

ZIP/Postal Code

59020

Country

France

Facility Name

Investigational Site Number 2404

City

Limoges Cedex

ZIP/Postal Code

87042

Country

France

Facility Name

Investigational Site Number 2401

City

Lyon Cedex 03

ZIP/Postal Code

69394

Country

France

Facility Name

Investigational Site Number 2409

City

Marseille

ZIP/Postal Code

13005

Country

France

Facility Name

Investigational Site Number 2402

City

Montpellier Cedex 5

ZIP/Postal Code

34000

Country

France

Facility Name

Investigational Site Number 2405

City

Nancy Cedex

ZIP/Postal Code

54036

Country

France

Facility Name

Investigational Site Number 2414

City

Nantes Cedex 01

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 2407

City

Nice Cedex

ZIP/Postal Code

06002

Country

France

Facility Name

Investigational Site Number 2410

City

Paris Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Investigational Site Number 2406

City

Rennes Cedex

ZIP/Postal Code

35033

Country

France

Facility Name

Investigational Site Number 2411

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Investigational Site Number 2011

City

Berlin

ZIP/Postal Code

10785

Country

Germany

Facility Name

Investigational Site Number 2001

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

Investigational Site Number 2000

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Investigational Site Number 2012

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Investigational Site Number 2004

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Investigational Site Number 2005

City

Gießen

ZIP/Postal Code

35385

Country

Germany

Facility Name

Investigational Site Number 2007

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Investigational Site Number 2008

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Investigational Site Number 2010

City

Offenbach

ZIP/Postal Code

63069

Country

Germany

Facility Name

Investigational Site Number 2009

City

Rostock

ZIP/Postal Code

18055

Country

Germany

Facility Name

Investigational Site Number 2003

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Investigational Site Number 2819

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Investigational Site Number 2827

City

Fidenza

ZIP/Postal Code

43036

Country

Italy

Facility Name

Investigational Site Number 2803

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Investigational Site Number 2814

City

Gallarate

ZIP/Postal Code

21013

Country

Italy

Facility Name

Investigational Site Number 2808

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 2812

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Investigational Site Number 2809

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Investigational Site Number 2813

City

Roma

ZIP/Postal Code

00152

Country

Italy

Facility Name

Investigational Site Number 2824

City

Roma

ZIP/Postal Code

00185

Country

Italy

Facility Name

Investigational Site Number 4602

City

'S Hertogenbosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Facility Name

Investigational Site Number 4605

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Investigational Site Number 4601

City

Nijmegen

ZIP/Postal Code

6525 GC

Country

Netherlands

Facility Name

Investigational Site Number 4604

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Investigational Site Number 3601

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Facility Name

Investigational Site Number 3604

City

Tønsberg

ZIP/Postal Code

3116

Country

Norway

Facility Name

Investigational Site Number 3008

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Investigational Site Number 3009

City

Bialystok

ZIP/Postal Code

15-402

Country

Poland

Facility Name

Investigational Site Number 3007

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Investigational Site Number 3005

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Investigational Site Number 3006

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

Facility Name

Investigational Site Number 3004

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

Investigational Site Number 3001

City

Poznan

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Investigational Site Number 3002

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Investigational Site Number 3003

City

Warszawa

ZIP/Postal Code

02-957

Country

Poland

Facility Name

Investigational Site Number 4201

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Investigational Site Number 4203

City

Lisboa

ZIP/Postal Code

1169-050

Country

Portugal

Facility Name

Investigational Site Number 3203

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Investigational Site Number 3205

City

Moscow

ZIP/Postal Code

125015

Country

Russian Federation

Facility Name

Investigational Site Number 3207

City

Nizhny Novgorod

ZIP/Postal Code

603076

Country

Russian Federation

Facility Name

Investigational Site Number 3208

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

Investigational Site Number 3201

City

St-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Investigational Site Number 3202

City

St-Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

Facility Name

Investigational Site Number 3206

City

St-Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Investigational Site Number 3401

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Investigational Site Number 1802

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Investigational Site Number 5003

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Investigational Site Number 5006

City

Izmir

ZIP/Postal Code

35380

Country

Turkey

Facility Name

Investigational Site Number 5005

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Investigational Site Number 5001

City

Sihhiye / Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 3504

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Investigational Site Number 3505

City

Ivano-Frankovsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Investigational Site Number 3506

City

Kharkiv

ZIP/Postal Code

61018

Country

Ukraine

Facility Name

Investigational Site Number 3510

City

Kharkiv

ZIP/Postal Code

61178

Country

Ukraine

Facility Name

Investigational Site Number 3508

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Investigational Site Number 3502

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Investigational Site Number 3509

City

Uzhgorod

ZIP/Postal Code

88018

Country

Ukraine

Facility Name

Investigational Site Number 3507

City

Vinnitsa

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Investigational Site Number 3501

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Investigational Site Number 2604

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Investigational Site Number 2607

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

Investigational Site Number 2608

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Investigational Site Number 2600

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Investigational Site Number 2601

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Investigational Site Number 2609

City

Plymouth

ZIP/Postal Code

PL6 8BX

Country

United Kingdom

Facility Name

Investigational Site Number 2606

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Investigational Site Number 2602

City

Stoke On Trent

ZIP/Postal Code

ST4 7LN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35485424

Citation

Sprenger T, Kappos L, Sormani MP, Miller AE, Poole EM, Cavalier S, Wuerfel J. Effects of teriflunomide treatment on cognitive performance and brain volume in patients with relapsing multiple sclerosis: Post hoc analysis of the TEMSO core and extension studies. Mult Scler. 2022 Oct;28(11):1719-1728. doi: 10.1177/13524585221089534. Epub 2022 Apr 29.

Results Reference

derived

PubMed Identifier

33023488

Citation

Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

Results Reference

derived

PubMed Identifier

31198103

Citation

Sprenger T, Kappos L, Radue EW, Gaetano L, Mueller-Lenke N, Wuerfel J, Poole EM, Cavalier S. Association of brain volume loss and long-term disability outcomes in patients with multiple sclerosis treated with teriflunomide. Mult Scler. 2020 Sep;26(10):1207-1216. doi: 10.1177/1352458519855722. Epub 2019 Jun 14.

Results Reference

derived

PubMed Identifier

28680917

Citation

Sormani MP, Truffinet P, Thangavelu K, Rufi P, Simonson C, De Stefano N. Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e379. doi: 10.1212/NXI.0000000000000379. eCollection 2017 Sep.

Results Reference

derived

Learn more about this trial

Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

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Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial