Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

Sanofi

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon-β; Drug: Placebo (for Teriflunomide); Drug: Teriflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489489

PDY6045

2006-003134-14 (EudraCT Number)

HMR1726D-2003 (Other Identifier)

Details and patient eligibility

About

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

Secondary objectives were:

• to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β 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 IFN-β.

Full description

The study period per 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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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 IFN-β 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 3 patient groups, including a placebo group

Teriflunomide 7 mg + IFN-β

Experimental group

Description:

Teriflunomide 7 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks

Treatment:

Drug: Teriflunomide

Drug: Interferon-β

Teriflunomide 14 mg + IFN-β

Experimental group

Description:

Teriflunomide 14 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks

Treatment:

Drug: Teriflunomide

Drug: Interferon-β

Placebo + IFN-β

Placebo Comparator group

Description:

Placebo (for Teriflunomide) once daily concomitantly with Interferon-β (IFN-β) for 24 weeks

Treatment:

Drug: Placebo (for Teriflunomide)

Drug: Interferon-β