Clinical trial NCT00751881: An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: relapsing multiple sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 1169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.

Detailed description: The study consists of:

* A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
* An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

The overall treatment period was followed by a 4-week elimination follow-up period.

Eligibility criteria: Inclusion Criteria:

* Relapsing multiple sclerosis,
* Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
* Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
* Pregnant or nursing woman,
* Alcohol or drug abuse,
* Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
* Human immunodeficiency virus (HIV) positive,
* 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.

Primary outcomes:
measure: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate
timeFrame: Core treatment period between 48 - 152 weeks depending on time of enrollment
Secondary outcomes:
measure: Core Treatment Period: Time to Disability Progression
timeFrame: Core treatment period between 48 - 152 weeks depending on time of enrollment
measure: Core Treatment Period: Time Without Relapse
timeFrame: Core treatment period between 48 - 152 weeks depending on time of enrollment
measure: Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score
timeFrame: Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48
measure: Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score
timeFrame: Baseline (before randomization), Week 12, Week 24 and Week 48
measure: Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score
timeFrame: Baseline (before randomization) and up to Week 152
measure: Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores
timeFrame: Baseline (before randomization), Week 12, Week 24 and Week 48
measure: Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores
timeFrame: Baseline (before randomization) and up to Week 152
measure: Core Treatment Period: Overview of Adverse Events
timeFrame: From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first
measure: Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)
timeFrame: From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period
measure: Extension Treatment Period: Time to Disability Progression
timeFrame: Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)
measure: Extension Treatment Period: ARR: Poisson Regression Estimate
timeFrame: Extension treatment period (Maximum: 174 weeks)
Other outcomes:
measure: Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
timeFrame: From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first
Locations:
city: Phoenix
country: United States
facility: Sanofi-Aventis Investigational Site Number 840041
state: Arizona
city: Tucson
country: United States
facility: Sanofi-Aventis Investigational Site Number 840084
state: Arizona
city: Loma Linda
country: United States
facility: Sanofi-Aventis Investigational Site Number 840008
state: California
city: Modesto
country: United States
facility: Sanofi-Aventis Investigational Site Number 840034
state: California
city: Fort Collins
country: United States
facility: Sanofi-Aventis Investigational Site Number 840090
state: Colorado
city: Fairfield
country: United States
facility: Sanofi-Aventis Investigational Site Number 840011
state: Connecticut
city: Maitland
country: United States
facility: Sanofi-Aventis Investigational Site Number 840013
state: Florida
city: Ocala
country: United States
facility: Sanofi-Aventis Investigational Site Number 840083
state: Florida
city: Ormond Beach
country: United States
facility: Sanofi-Aventis Investigational Site Number 840086
state: Florida
city: Sarasota
country: United States
facility: Sanofi-Aventis Investigational Site Number 840025
state: Florida
city: St. Petersburg
country: United States
facility: Sanofi-Aventis Investigational Site Number 840015
state: Florida
city: Sunrise
country: United States
facility: Sanofi-Aventis Investigational Site Number 840033
state: Florida
city: Elk Grove Village
country: United States
facility: Sanofi-Aventis Investigational Site Number 840063
state: Illinois
city: Flossmoor
country: United States
facility: Sanofi-Aventis Investigational Site Number 840064
state: Illinois
city: Ft Wayne
country: United States
facility: Sanofi-Aventis Investigational Site Number 840039
state: Indiana
city: Indianapolis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840012
state: Indiana
city: Des Moines
country: United States
facility: Sanofi-Aventis Investigational Site Number 840016
state: Iowa
city: Clinton Township
country: United States
facility: Sanofi-Aventis Investigational Site Number 840069
state: Michigan
city: Grand Rapids
country: United States
facility: Sanofi-Aventis Investigational Site Number 840075
state: Michigan
city: Traverse City
country: United States
facility: Sanofi-Aventis Investigational Site Number 840061
state: Michigan
city: Minneapolis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840076
state: Minnesota
city: Tupelo
country: United States
facility: Sanofi-Aventis Investigational Site Number 840079
state: Mississippi
city: St. Louis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840088
state: Missouri
city: Syracuse
country: United States
facility: Sanofi-Aventis Investigational Site Number 840060
state: New York
city: Charlotte
country: United States
facility: Sanofi-Aventis Investigational Site Number 840029
state: North Carolina
city: Bismarck
country: United States
facility: Sanofi-Aventis Investigational Site Number 840074
state: North Dakota
city: Cincinnati
country: United States
facility: Sanofi-Aventis Investigational Site Number 840026
state: Ohio
city: Dayton
country: United States
facility: Sanofi-Aventis Investigational Site Number 840078
state: Ohio
city: Tulsa
country: United States
facility: Sanofi-Aventis Investigational Site Number 840066
state: Oklahoma
city: Portland
country: United States
facility: Sanofi-Aventis Investigational Site Number 840024
state: Oregon
city: Philadelphia
country: United States
facility: Sanofi-Aventis Investigational Site Number 840073
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sanofi-Aventis Investigational Site Number 840022
state: Pennsylvania
city: Greenville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840068
state: South Carolina
city: Cordova
country: United States
facility: Sanofi-Aventis Investigational Site Number 840071
state: Tennessee
city: Nashville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840036
state: Tennessee
city: San Antonio
country: United States
facility: Sanofi-Aventis Investigational Site Number 840007
state: Texas
city: Bennington
country: United States
facility: Sanofi-Aventis Investigational Site Number 840006
state: Vermont
city: Seattle
country: United States
facility: Sanofi-Aventis Investigational Site Number 840089
state: Washington
city: Charleston
country: United States
facility: Sanofi-Aventis Investigational Site Number 840020
state: West Virginia
city: Bedford Park
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036005
city: Chatswood
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036006
city: Fitzroy
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036003
city: Geelong
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036004
city: Heidelberg
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036008
city: New Lambton
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036002
city: Sydney
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036001
city: Wien
country: Austria
facility: Sanofi-Aventis Investigational Site Number 040001
city: Grodno
country: Belarus
facility: Sanofi-Aventis Investigational Site Number 112105
city: Minsk
country: Belarus
facility: Sanofi-Aventis Investigational Site Number 112102
city: Minsk
country: Belarus
facility: Sanofi-Aventis Investigational Site Number 112101
city: Minsk
country: Belarus
facility: Sanofi-Aventis Investigational Site Number 112104
city: Vitebsk
country: Belarus
facility: Sanofi-Aventis Investigational Site Number 112103
city: Brugge
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056004
city: Leuven
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056002
city: Melsbroek
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056001
city: Sijsele-Damme
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056003
city: Gatineau
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124004
city: Kingston
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124002
city: Montreal
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124007
city: Ottawa
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124008
city: Quebec
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124001
city: Regina
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124003
city: Saint John
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124006
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152006
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152007
city: Viña Del Mar
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152002
city: Baotou
country: China
facility: Sanofi-Aventis Investigational Site Number 156023
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156031
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156006
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156010
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156005
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156032
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156024
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156030
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156001
city: Beijing
country: China
facility: Sanofi-Aventis Investigational Site Number 156008
city: Changchun
country: China
facility: Sanofi-Aventis Investigational Site Number 156007
city: Chengdu
country: China
facility: Sanofi-Aventis Investigational Site Number 156002
city: Guangzhou
country: China
facility: Sanofi-Aventis Investigational Site Number 156025
city: Guangzhou
country: China
facility: Sanofi-Aventis Investigational Site Number 156012
city: Haikou
country: China
facility: Sanofi-Aventis Investigational Site Number 156027
city: Hangzhou
country: China
facility: Sanofi-Aventis Investigational Site Number 156021
city: Jinan
country: China
facility: Sanofi-Aventis Investigational Site Number 156033
city: Nanjing
country: China
facility: Sanofi-Aventis Investigational Site Number 156034
city: Nanjing
country: China
facility: Sanofi-Aventis Investigational Site Number 156011
city: Qingdao
country: China
facility: Sanofi-Aventis Investigational Site Number 156019
city: Shanghai
country: China
facility: Sanofi-Aventis Investigational Site Number 156029
city: Shanghai
country: China
facility: Sanofi-Aventis Investigational Site Number 156016
city: Shenyang
country: China
facility: Sanofi-Aventis Investigational Site Number 156009
city: Shijiazhuang
country: China
facility: Sanofi-Aventis Investigational Site Number 156022
city: Suzhou
country: China
facility: Sanofi-Aventis Investigational Site Number 156018
city: Taiyuan
country: China
facility: Sanofi-Aventis Investigational Site Number 156028
city: Tianjin
country: China
facility: Sanofi-Aventis Investigational Site Number 156003
city: Tianjin
country: China
facility: Sanofi-Aventis Investigational Site Number 156035
city: Wenzhou
country: China
facility: Sanofi-Aventis Investigational Site Number 156017
city: Wuhan
country: China
facility: Sanofi-Aventis Investigational Site Number 156004
city: Xi'An
country: China
facility: Sanofi-Aventis Investigational Site Number 156014
city: Xi'An
country: China
facility: Sanofi-Aventis Investigational Site Number 156015
city: Brno
country: Czech Republic
facility: Sanofi-Aventis Investigational Site Number 203001
city: Ostrava - Poruba
country: Czech Republic
facility: Sanofi-Aventis Investigational Site Number 203002
city: Teplice
country: Czech Republic
facility: Sanofi-Aventis Investigational Site Number 203004
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233002
city: Tartu
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233001
city: Besancon
country: France
facility: Sanofi-Aventis Investigational Site Number 250005
city: Dijon Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250008
city: Lyon Cedex 03
country: France
facility: Sanofi-Aventis Investigational Site Number 250001
city: Nantes Cedex 01
country: France
facility: Sanofi-Aventis Investigational Site Number 250007
city: Nice Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250006
city: Nimes
country: France
facility: Sanofi-Aventis Investigational Site Number 250002
city: Poissy
country: France
facility: Sanofi-Aventis Investigational Site Number 250003
city: Bamberg
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276010
city: Bayreuth
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276003
city: Berlin
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276005
city: Erlangen
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276001
city: Gießen
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276006
city: Hannover
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276004
city: Leipzig
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276007
city: Magdeburg
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276009
city: Wiesbaden
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276002
city: Athens
country: Greece
facility: Sanofi-Aventis Investigational Site Number 300001
city: Thessaloniki
country: Greece
facility: Sanofi-Aventis Investigational Site Number 300006
city: Monterrey
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 484005
city: México
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 484003
city: 'S Hertogenbosch
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528003
city: Breda
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528001
city: Groesbeek
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528002
city: Nieuwegein
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528004
city: Sittard-Geleen
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528006
city: Cebu City
country: Philippines
facility: Sanofi-Aventis Investigational Site Number 608004
city: Makati City
country: Philippines
facility: Sanofi-Aventis Investigational Site Number 608002
city: Manila
country: Philippines
facility: Sanofi-Aventis Investigational Site Number 608001
city: Quezon City
country: Philippines
facility: Sanofi-Aventis Investigational Site Number 608003
city: Gdansk
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616002
city: Lodz
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616005
city: Lublin
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616001
city: Szczecin
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616004
city: Warszawa 44
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616003
city: Bacau
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642006
city: Brasov
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642005
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642001
city: Oradea
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642007
city: Bratislava 2
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703003
city: Bratislava 2
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703005
city: Martin
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703001
city: Presov
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703006
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724001
city: Getafe
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724007
city: Girona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724002
city: Madrid
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724004
city: Sevilla
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724003
city: Stockholm
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752002
city: Stockholm
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752001
city: Stockholm
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752003
city: Bangkok-Noi
country: Thailand
facility: Sanofi-Aventis Investigational Site Number 764002
city: Bangkok
country: Thailand
facility: Sanofi-Aventis Investigational Site Number 764001
city: Manouba
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 788003
city: Sfax
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 788004
city: Tunis
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 788002
city: Tunis
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 788001
city: Edirne
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792011
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792009
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792001
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792007
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792010
city: Izmir
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792012
city: Kocaeli
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792002
city: Manisa
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792003
city: Samsun
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792005
city: Trabzon
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792004
city: Chernihiv
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804101
city: Dnipropetrovsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804103
city: Donetsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804107
city: Donetsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804117
city: Ivano-Frankovsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804119
city: Kharkiv
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804102
city: Kharkov
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804109
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804115
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804116
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804108
city: Lutsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804111
city: Lutsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804124
city: Lviv
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804114
city: Lviv
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804121
city: Poltava
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804120
city: Vinnytsya
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804105
city: Zaporizhya
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804118
city: Zaporizhzhia
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804104
city: Zaporozhye
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804122
city: Edinburgh
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826002
city: Haywards Heath
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826004
city: Irvine
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826001
city: Leeds
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826003
city: Salford
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Confavreux C, O'Connor P, Comi G, Freedman MS, Miller AE, Olsson TP, Wolinsky JS, Bagulho T, Delhay JL, Dukovic D, Truffinet P, Kappos L; TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Mar;13(3):247-56. doi: 10.1016/S1474-4422(13)70308-9. Epub 2014 Jan 23.
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.
citation: Miller AE, Olsson TP, Wolinsky JS, Comi G, Kappos L, Hu X, Xu X, Lublin AL, Truffinet P, Chavin J, Delhay JL, Benamor M, Purvis A, Freedman MS; TOWER investigators. Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study. Mult Scler Relat Disord. 2020 Nov;46:102438. doi: 10.1016/j.msard.2020.102438. Epub 2020 Aug 1.
citation: Qiu W, Huang DH, Hou SF, Zhang MN, Jin T, Dong HQ, Peng H, Zhang CD, Zhao G, Huang YN, Zhou D, Wu WP, Wang BJ, Li JM, Zhang XH, Cheng Y, Li HF, Li L, Lu CZ, Zhang X, Bu BT, Dong WL, Fan DS, Hu XQ, Xu XH; TOWER Trial Chinese Group. Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study. Chin Med J (Engl). 2018 Dec 5;131(23):2776-2784. doi: 10.4103/0366-6999.246067.
citation: Freedman MS, Morawski J, Thangavelu K. Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study. Mult Scler J Exp Transl Clin. 2018 May 16;4(2):2055217318775236. doi: 10.1177/2055217318775236. eCollection 2018 Apr-Jun.
citation: Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.