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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803049
• Other study ID #: LTS6050
• Secondary ID: 2006-003361-14
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2008
• Last updated: January 26, 2016
• Start date: October 2006
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) patients with relapse.

The secondary objective is to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

Description:

Patients completing the EFC6049 (HMR1726D/3001) study are given the opportunity to continue in the extension study;

• patients receiving teriflunomide 7 mg or 14 mg are blindly maintained on the same dose of teriflunomide.

• patients receiving placebo are randomized to teriflunomide 7 mg or 14 mg.

The study period per patient is broken down as follows:

• Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives,

• Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if patient continues on teriflunomide treatment by obtaining it's commercial form after end of the study.

The total duration of the extension is 292 weeks (about 6 years) from the first patient enrolled or until teriflunomide is commercially available in the country where patient lives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patient who has completed the previous double-blind placebo-controlled study EFC6049 and who does 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 patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• teriflunomide (HMR1726)
Tablet, oral administration once daily.

Locations

Country	Name	City	State
Austria	Investigational Site Number 1603	Graz
Austria	Investigational Site Number 1604	Innsbruck
Austria	Investigational Site Number 1601	Wien
Austria	Investigational Site Number 1602	Wien
Canada	Investigational Site Number 1208	Calgary
Canada	Investigational Site Number 1212	Gatineau
Canada	Investigational Site Number 1205	Greenfield Park
Canada	Investigational Site Number 1201	Halifax
Canada	Investigational Site Number 1206	London
Canada	Investigational Site Number 1203	Montreal
Canada	Investigational Site Number 1204	Ottawa
Canada	Investigational Site Number 1202	Quebec
Canada	Investigational Site Number 1211	St. John'S
Canada	Investigational Site Number 1209	Toronto
Canada	Investigational Site Number 1210	Vancouver
Canada	Investigational Site Number 1207	Winnipeg
Chile	Investigational Site Number 3801	Santiago
Chile	Investigational Site Number 3802	Santiago
Chile	Investigational Site Number 3803	Santiago
Chile	Investigational Site Number 3804	Santiago
Chile	Investigational Site Number 3805	Viña Del Mar
Czech Republic	Investigational Site Number 4101	Olomouc
Denmark	Investigational Site Number 4801	Glostrup
Denmark	Investigational Site Number 4804	Sønderborg
Denmark	Investigational Site Number 4802	Vejle
Estonia	Investigational Site Number 1502	Tallinn
Estonia	Investigational Site Number 1501	Tartu
Finland	Investigational Site Number 2203	Helsinki
Finland	Investigational Site Number 2206	Pori
Finland	Investigational Site Number 2201	Tampere
Finland	Investigational Site Number 2202	Turku
France	Investigational Site Number 2415	Besancon
France	Investigational Site Number 2403	Clermont Ferrand Cedex 1
France	Investigational Site Number 2408	Dijon
France	Investigational Site Number 2413	Lille Cedex
France	Investigational Site Number 2404	Limoges Cedex
France	Investigational Site Number 2401	Lyon Cedex 03
France	Investigational Site Number 2409	Marseille
France	Investigational Site Number 2402	Montpellier Cedex 5
France	Investigational Site Number 2405	Nancy Cedex
France	Investigational Site Number 2414	Nantes Cedex 01
France	Investigational Site Number 2407	Nice Cedex
France	Investigational Site Number 2410	Paris Cedex 12
France	Investigational Site Number 2406	Rennes Cedex
France	Investigational Site Number 2411	Toulouse
Germany	Investigational Site Number 2001	Berlin
Germany	Investigational Site Number 2011	Berlin
Germany	Investigational Site Number 2000	Bochum
Germany	Investigational Site Number 2012	Erbach
Germany	Investigational Site Number 2004	Essen
Germany	Investigational Site Number 2005	Gießen
Germany	Investigational Site Number 2007	Hannover
Germany	Investigational Site Number 2008	Münster
Germany	Investigational Site Number 2010	Offenbach
Germany	Investigational Site Number 2009	Rostock
Germany	Investigational Site Number 2003	Wiesbaden
Italy	Investigational Site Number 2819	Bari
Italy	Investigational Site Number 2827	Fidenza
Italy	Investigational Site Number 2803	Firenze
Italy	Investigational Site Number 2814	Gallarate
Italy	Investigational Site Number 2808	Milano
Italy	Investigational Site Number 2812	Padova
Italy	Investigational Site Number 2809	Pavia
Italy	Investigational Site Number 2813	Roma
Italy	Investigational Site Number 2824	Roma
Netherlands	Investigational Site Number 4602	'S Hertogenbosch
Netherlands	Investigational Site Number 4605	Breda
Netherlands	Investigational Site Number 4601	Nijmegen
Netherlands	Investigational Site Number 4604	Sittard-Geleen
Norway	Investigational Site Number 3601	Oslo
Norway	Investigational Site Number 3604	Tønsberg
Poland	Investigational Site Number 3008	Bialystok
Poland	Investigational Site Number 3009	Bialystok
Poland	Investigational Site Number 3007	Gdansk
Poland	Investigational Site Number 3005	Lodz
Poland	Investigational Site Number 3004	Lublin
Poland	Investigational Site Number 3006	Lublin
Poland	Investigational Site Number 3001	Poznan
Poland	Investigational Site Number 3002	Warszawa
Poland	Investigational Site Number 3003	Warszawa
Portugal	Investigational Site Number 4201	Coimbra
Portugal	Investigational Site Number 4203	Lisboa
Russian Federation	Investigational Site Number 3203	Moscow
Russian Federation	Investigational Site Number 3205	Moscow
Russian Federation	Investigational Site Number 3207	Nizhny Novgorod
Russian Federation	Investigational Site Number 3208	Novosibirsk
Russian Federation	Investigational Site Number 3201	St-Petersburg
Russian Federation	Investigational Site Number 3202	St-Petersburg
Russian Federation	Investigational Site Number 3206	St-Petersburg
Sweden	Investigational Site Number 3401	Stockholm
Switzerland	Investigational Site Number 1802	Basel
Turkey	Investigational Site Number 5003	Izmir
Turkey	Investigational Site Number 5006	Izmir
Turkey	Investigational Site Number 5005	Kocaeli
Turkey	Investigational Site Number 5001	Sihhiye / Ankara
Ukraine	Investigational Site Number 3504	Dnipropetrovsk
Ukraine	Investigational Site Number 3505	Ivano-Frankovsk
Ukraine	Investigational Site Number 3506	Kharkiv
Ukraine	Investigational Site Number 3510	Kharkiv
Ukraine	Investigational Site Number 3508	Lviv
Ukraine	Investigational Site Number 3502	Odessa
Ukraine	Investigational Site Number 3509	Uzhgorod
Ukraine	Investigational Site Number 3507	Vinnitsa
Ukraine	Investigational Site Number 3501	Zaporizhzhya
United Kingdom	Investigational Site Number 2604	Dundee
United Kingdom	Investigational Site Number 2607	London
United Kingdom	Investigational Site Number 2608	London
United Kingdom	Investigational Site Number 2600	Newcastle Upon Tyne
United Kingdom	Investigational Site Number 2601	Nottingham
United Kingdom	Investigational Site Number 2609	Plymouth
United Kingdom	Investigational Site Number 2606	Sheffield
United Kingdom	Investigational Site Number 2602	Stoke On Trent
United States	Investigational Site Number 1037	Allentown	Pennsylvania
United States	Investigational Site Number 1033	Detroit	Michigan
United States	Investigational Site Number 1038	Ft. Wayne	Indiana
United States	Investigational Site Number 1032	Maitland	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Chile,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		Up to a maximum of 292 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives	Yes
Secondary	Time to disability progression as assessed by Expanded Disability Status Scale (EDSS)		Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives	No
Secondary	Proportion of patients free of disability progression		Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives	No
Secondary	Annualized relapse rate (number of confirmed relapses per patient-year)		Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives	No
Secondary	Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain MRI		Up to a maximum of 288 weeks	No