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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Teriflunomide; Drug: Glatiramer Acetate (GA); Drug: Placebo (for teriflunomide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475865

2006-004893-29 (EudraCT Number)

HMR1726D-2004 (Other Identifier)

PDY6046

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 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.

Full 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.

Enrollment: 123 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 3 patient groups, including a placebo group

Placebo + GA

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (for teriflunomide)

Drug: Glatiramer Acetate (GA)

Teriflunomide 7 mg + GA

Experimental group

Description:

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

Treatment:

Drug: Glatiramer Acetate (GA)

Drug: Teriflunomide

Teriflunomide 14 mg + GA

Experimental group

Description:

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

Treatment:

Drug: Glatiramer Acetate (GA)

Drug: Teriflunomide