http://www.mssociety.ca/en/research/PT011026.htm

October 26, 2001
Medical Update Memo

Summary

Volunteers are needed to find out if a modified form of a drug used to treat rheumatoid arthritis would be effective in relapsing-remitting MS. The clinical trial of oral teriflunomide (taken by mouth) has just begun at nine MS clinics across Canada. Study principal investigator is Dr. Paul O'Connor, director of the MS Clinic, St. Michael's Hospital, Toronto. It is sponsored by Aventis Inc. The arthritis drug is known as Arava, however, the formulation of the drug being used in the MS study is considerably different. Please see eligibility criteria and contact information below.

Details

Volunteers are needed to find out if a modified form of a drug used to treat rheumatoid arthritis would be effective in relapsing-remitting MS. The clinical trial of oral teriflunomide (taken by mouth) has just begun at nine MS clinics across Canada. Study principal investigator is Dr. Paul O'Connor, director of the MS Clinic, St. Michael's Hospital, Toronto. It is sponsored by Aventis Inc. The arthritis drug is known as Arava®, however, the formulation of the drug being used in the MS study is considerably different.

Studies of teriflunomide in laboratory animals with the MS-like disease called experimental allergic encephalomyelitis have been promising and have led to this small Phase II study to determine whether teriflunomide can be used safely in people with MS and whether it has any impact on the disease. It is believed that teriflunomide works primarily on modulating the responses of T-cells within the immune system.

A total of 180 people with relapsing-remitting MS who meet study criteria are required for the study. The study is double-blinded (neither the participants nor their care team will know who is on active treatment) and placebo controlled. Participants will receive either 7 mg or 14 mg of oral teriflunomide or an inactive placebo for 36 weeks with MRI scans, blood tests and neurological examinations every six weeks. After this period, participants will be offered the choice of taking the low or high dose of teriflunomide in the extension phase of the study.

Potential side effects

The version of the drug used for rheumatoid arthritis is considered safe and generally well tolerated. Since teriflunomide has not been used before in people with MS, study participants will be monitored carefully for the development of significant side effects.

Eligibility criteria

To be eligible, participants must:

• have a diagnosis of clinically definite relapsing-remitting MS;
• have had two MS attacks in the past three years, one in the past 12 months;
• be able to walk with or without a cane (Expanded Disability Status Scale (EDSS) rating of 6 or less);
• not have been on any of the approved disease-modifying drugs for four months prior to study entry;
• be between 18 and 65 years of age