Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

NCT ID: NCT00475865

Last Updated: 2012-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-10-31

Brief Summary

The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].

The secondary objectives were:

• to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue;
• to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.

Detailed Description

The duration of the study period for a participant was approximatively 44 weeks broken down as follows:

• Screening period up to 4 weeks,
• 24-week double-blind treatment period*,
• 16-week post-treatment elimination follow-up period.

'*' Participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.

Conditions

Multiple Sclerosis

Keywords

MS; glatiramer acetate; adjunctive therapy; relapses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo + GA

Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate (GA) for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo (for teriflunomide)

Intervention Type: DRUG

Film-coated tablet

Oral administration

Glatiramer Acetate (GA)

Intervention Type: DRUG

Solution in prefilled syringe for subcutaneous injection

Teriflunomide 7 mg + GA

Teriflunomide 7 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks

Group Type: EXPERIMENTAL

Teriflunomide

Intervention Type: DRUG

Film-coated tablet

Oral administration

Glatiramer Acetate (GA)

Intervention Type: DRUG

Solution in prefilled syringe for subcutaneous injection

Teriflunomide 14 mg + GA

Teriflunomide 14 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks

Group Type: EXPERIMENTAL

Teriflunomide

Intervention Type: DRUG

Film-coated tablet

Oral administration

Glatiramer Acetate (GA)

Intervention Type: DRUG

Solution in prefilled syringe for subcutaneous injection

Interventions

Teriflunomide

Film-coated tablet

Oral administration

Intervention Type: DRUG

Placebo (for teriflunomide)

Film-coated tablet

Oral administration

Intervention Type: DRUG

Glatiramer Acetate (GA)

Solution in prefilled syringe for subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

HMR1726; Copaxone®

Eligibility Criteria

Inclusion Criteria

• Definite MS diagnosis according to McDonald's criteria;
• Relapsing clinical course, with or without progression;
• Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory);
• Stable dose of Glatiramer Acetate [GA] for at least 26 weeks prior to the screening visit;
• No onset of MS relapse in the preceding 60 days prior to randomization;
• Clinically stable for 4 weeks prior to randomization.

Exclusion Criteria

• Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
• Pregnant or nursing woman;
• Alcohol or drug abuse;
• Use of cladribine, Mitoxantrone, or other immunosuppressant agents such as Azathioprine, Cyclophosphamide, Cyclosporin, Methotrexate or Mycophenolate before enrollment;
• Human immunodeficiency virus [HIV] positive status;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Vienna, , Austria

Sanofi-Aventis Administrative Office

Laval, , Canada

Sanofi-Aventis Administrative Office

Berlin, , Germany

Sanofi-Aventis Administrative Office

Milan, , Italy

Sanofi-Aventis Administrative Office

Guildford, , United Kingdom

Countries

United States; Austria; Canada; Germany; Italy; United Kingdom

References

Freedman MS, Wolinsky JS, Truffinet P, Comi G, Kappos L, Miller AE, Olsson TP, Benamor M, Chambers S, O'Connor PW. A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec.

Reference Type: DERIVED

PMID: 28607708 (View on PubMed)

Other Identifiers

2006-004893-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HMR1726D-2004

Identifier Type: OTHER

Identifier Source: secondary_id

PDY6046

Identifier Type: -

Identifier Source: org_study_id