Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (TEMSO)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo (for teriflunomide); Drug: Teriflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134563

EFC6049

HMR1726D/3001 (Other Identifier)

2004-000555-42 (EudraCT Number)

Details and patient eligibility

About

The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

• to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue;
• to evaluate the safety and tolerability of teriflunomide.

Full description

The study period per participant was approximatively 128 weeks broken down as follows:

• Screening period up to 4 weeks,
• 108-week double-blind treatment period (approximatively 2 years)*,
• 16-week post-treatment elimination follow-up period.

'*' Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049.

Enrollment: 1,088 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Multiple sclerosis [MS] subject who was ambulatory (EDSS of ≤ 5.5)
• Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
• Meeting McDonald's criteria for MS diagnosis;
• Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
• No relapse onset in the preceding 60 days prior to randomization;
• Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [ACTH] or systemic steroid treatment.

Exclusion criteria

• Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
• Significantly impaired bone marrow function;
• 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;
• Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,088 participants in 3 patient groups, including a placebo group

Teriflunomide 7 mg

Experimental group

Description:

Teriflunomide 7 mg once daily for 108 weeks

Treatment:

Drug: Teriflunomide

Teriflunomide 14 mg

Experimental group

Description:

Teriflunomide 14 mg once daily for 108 weeks

Treatment:

Drug: Teriflunomide

Placebo

Placebo Comparator group

Description:

Placebo (for teriflunomide) once daily for 108 weeks

Treatment:

Drug: Placebo (for teriflunomide)