Learn about a Clinical Research Opportunity
This study will assess the safety and effectiveness of an investigational study medication versus placebo (an inactive substance which contains no active medication) in people ages 18-55 years old with RMS.
The investigational medication used in this study is called teriflunomide (ter-i-flün-ō-mïde). It is derived from leflunomide (le-flü-nō-mïde), also known as Arava®. Arava® is already approved in many countries for the treatment of rheumatoid arthritis, another autoimmune disease.
About 1110 people will participate in this study at approximately 200 research centers throughout the world. For those who qualify for the study following the screening process, participation requires attending regular study visits over a period of approximately 16 months to approximately 3 years and 4 months.
Why Should I Participate in this Clinical Research Study?
If you qualify to participate in this clinical research study you will receive:
- Healthcare monitoring of your condition as it relates to the clinical study. This is true whether you are assigned to the treatment (teriflunomide) or placebo groups.
- Up to 3 years of study related medical care and study medication - all provided at no cost to you.
- Potential access to one of the first investigational oral study medications for RMS.
Who Can Participate in this Clinical Research Study?
Check these requirements to determine if you may qualify.
- Are you between 18 to 55 years old?
- Have you been diagnosed with RMS?
- Have you had one relapse episode (return of symptoms) in the past 12 months or two relapses in the past 24 months?
Tell Me More About The Study
Participants are randomly assigned (like flipping a coin) to one of three study treatment groups, as pictured below. Two of these groups receive teriflunomide. The only difference between these two groups is the amount of medication. The third group receives placebo.
The study medication is an oral tablet. Participants cannot choose their treatment group.
| Group | Study Medication | Type of Medication | Number of Participants |
|---|---|---|---|
| 1 | Receives teriflunomide | Oral tablet | 370 |
| 2 | Receives teriflunomide | Oral tablet | 370 |
| 3 | Receives placebo | Oral tablet | 370 |
In a placebo controlled study, there is a chance of receiving or not receiving the investigational medication. In this study, each participant has a 2-in-3 chance of receiving the investigational medication and a 1-in-3 chance of receiving the placebo.
The placebo tablet looks exactly like teriflunomide, but does not contain any active medication. Participants do not know to which of the oral study medication groups they are assigned. Studies designed this way are necessary. In this way, results from those taking teriflunomide can be compared to those not taking this investigational oral medicine.
Each participant group is of equal importance to this study's success. Each group and each participant makes a valuable contribution to advancing multiple sclerosis research and knowledge.