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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Teriflunomide (HMR1726)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803049

2006-003361-14 (EudraCT Number)

LTS6050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 742 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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742 participants in 4 patient groups

Placebo/Teriflunomide 7 mg

Experimental group

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.

Treatment:

Drug: Teriflunomide (HMR1726)

Teriflunomide 7 mg/7 mg

Experimental group

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.

Treatment:

Drug: Teriflunomide (HMR1726)

Placebo/Teriflunomide 14 mg

Experimental group

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.

Treatment:

Drug: Teriflunomide (HMR1726)

Teriflunomide 14 mg/14 mg

Experimental group

Description:

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.

Treatment:

Drug: Teriflunomide (HMR1726)