Overview

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

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
(T,G)-A-L
Glatiramer Acetate
Teriflunomide
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.