What is the TERMS study?
The TERMS (Tovaxin for Early Relapsing Multiple Sclerosis) study is testing Tovaxin™, an autologous
T-Cell vaccination in patients with Clinically Isolated Syndrome or Relapsing-Remitting
Multiple Sclerosis. An autologous T-Cell vaccine, is made from the patient's own
myelin reactive T-cells and is unique for each person. This type of therapy is hoped to attack the underlying cause of MS, not just the symptoms.
Where is the study being conducted?
The TERMS study is being conducted at up to 40 clinical sites in the United States. See the "Locations" page of this website for research center locations.
How can I participate?
To qualify for the study, you must meet certain screening criteria:
- Between 18 to 55 years old
- Must have a neurologist's diagnosis of Clinically Isolated Syndrome or Relapsing-Remitting
Multiple Sclerosis less than 10 years
- Not currently taking disease-modifying treatments for MS. Subjects will be allowed
to be screened if they have discontinued treatment due to side effects or failure
- Presence of myelin reactive T-cells in the blood
Other criteria apply. Potential participants will be evaluated for qualification, first by a short interview, and then by a neurologist during an office visit. If you qualify, you will have the option to join the study, which will continue for a year. Before you decide to join, you will be informed in detail about the study, and have a chance to have all your questions answered.
Study participants will receive either subcutaneous injections of the T-Cell vaccine, Tovaxin™ or placebo (no medication),
at 0, 4, 8, 12 and 24 weeks. This is a randomized study; you have a 67% chance of receiving Tovaxin™ and a 33% chance of receiving placebo. Neither you nor your study physician will know which you are getting.
All patients who complete the TERMS study will be eligible to participate in an optional one-year extension study in which they will receive Tovaxin under an open-label protocol. This extension study will not use placebo.
Are there any risks?
All medications have risks. Tovaxin™ has been studied in MS patients since
2001. To date, at least seven clinical studies using
various formulations of T-cell vaccination have been reported. The T-cell vaccines used in those previous studies vary from the one used in the TERMS study. There are three ongoing studies, including TERMS, using the current vaccine. The study staff will review the Informed Consent document with you, which includes a complete description of the known risks associated with Tovaxin™ and study participation.
How will this benefit me?
Study participation provides you a thorough assessment and evaluation, which may provide you and your doctor with additional information about your health. You may learn new information about Multiple Sclerosis and your own condition. You will receive physicals and neurological exams, lab tests, MRIs and study medication at no cost to you. All study related procedures will be provided by a board certified neurologist.
Clinical trials are one of the most important steps in advancing medical care and optimal usage of treatment therapies. As a study participant, you are contributing to medical research and the understanding of this disease. Your participation in this study may help researchers to develop a new treatment for Multiple Sclerosis.
What if I change my mind?
You are free to withdraw from the study at any time without having to give a reason and without affecting your future medical treatment.
Confidentiality
We make every effort to maintain your confidentiality and are fully compliant with laws and regulations that protect the privacy of your medical information. Your name will not be revealed in any publication that may result from this research. Your study physicians and nurses need to have access to your medical records, as will the study sponsor, the Institutional Review Board (IRB) and the Food and Drug Administration (FDA).
What will it cost?
You will not be charged for study-related evaluations, tests, or procedures. The study sponsor will pay for these costs.
