An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis (TOWER)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Teriflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751881

EFC10531

2007-004452-36 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

• To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  • Fatigue;
  • Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.

• To evaluate the safety and tolerability of teriflunomide.

Full description

The study consists of:

• A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
• An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

The overall treatment period was followed by a 4-week elimination follow-up period.

Enrollment: 1,169 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsing multiple sclerosis,
• Two relapses in prior 2 years or one relapse in prior year.

Exclusion criteria

• Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
• Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
• Pregnant or nursing woman,
• Alcohol or drug abuse,
• Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
• Human immunodeficiency virus (HIV) positive,
• 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 participant'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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1,169 participants in 3 patient groups, including a placebo group

Teriflunomide 7 mg / 14 mg

Experimental group

Description:

Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Treatment:

Drug: Teriflunomide

Teriflunomide 14 mg / 14 mg

Experimental group

Description:

Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Treatment:

Drug: Teriflunomide

Placebo / Teriflunomide 14 mg

Placebo Comparator group

Description:

Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Treatment:

Drug: Placebo

Drug: Teriflunomide