Clinical trials help to determine if a drug is safe and effective for people with MS. People with MS who are willing to volunteer in these studies make it possible for all of us to look forward to new and better therapies.
Clinical Trial Basics
The process is complicated. Many factors are involved in making sure that a study is conducted properly and that the results are valid. The U.S. Food and Drug Administration requires therapies to undergo three phases of clinical trials before they can be approved to treat people with MS:
- Phase I – The first step is to determine safety. In a small number of healthy volunteers or persons with MS, the investigators determine how the human body reacts to the therapy.
- Phase II – If the therapy proves to be safe, studies begin to determine the effectiveness of the drug in people with MS. These studies may last several months or several years, and involve larger numbers of people. The study is "controlled"—that is, the drug is compared with the standard treatment, or an inactive placebo.
- Phase III – If an MS drug shows effectiveness, an even larger study is conducted in hundreds of people to gain a better understanding of the drug’s effectiveness and possible side effects. These multi-center studies can span several years and several countries.
- Following FDA approval, post-marketing studies (phase IV) might be conducted to assess long-term safety and effectiveness.
A selection of local trials (approved by the National MS Society) are detailed on this page:
Summary
Researchers nationwide are enrolling people who have relapsing forms of MS in a study to evaluate the effects of Tysabri (natalizumab, Biogen Idec and Elan Pharmaceuticals) on responses to common vaccines in order to understand better the immune responses of patients with MS on Tysabri. In Southern California, Dr. Jack H. Florin in Fullerton is a Principal Investigator.
Rationale
Tysabri is a monoclonal antibody that has been approved for the treatment of relapsing forms of MS. Tysabri is designed to hamper the movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier,” and into the brain and spinal cord. The drug inhibits this movement by attaching to alpha 4-integrin, a protein on the surface of immune T-cells that normally enables them to adhere to and then pass through the blood-brain barrier.
Vaccines are an important part of healthy living with MS; most are safe for people with this disease. No information is available on how Tysabri affects the immune response that occurs when people receive vaccinations. This study is designed to provide this information.
Eligibility and Details
To enroll in this study, people must be between 18 and 60 years of age and have a diagnosis of relapsing forms of MS.
Participants will be randomly assigned to one of two groups: approximately 23 participants will receive Tysabri infusions (300mg) intravenously every four weeks for at least nine months; along with one tetanus vaccine and 3 immunizations of KLH, a vaccine used to study the immune system. Investigators are using these vaccinations to determine response to a vaccine that participants would not have received before (KLH) and one that they would have received before (tetanus).
The second group of approximately 23 participants will receive no Tysabri but will have the same vaccinations as first group: three immunizations of KLH and one tetanus vaccine.
All participants will have blood drawn to determine effects on the immune response.
Tysabri, KLH and Tetanus and study-related testing are provided at no cost to patients in the study.
Contact Information
Kellie Simpson, MS, NP
Clinical Coordinator
Fullerton Neurology and Headache Center
100 Laguna Rd. # 208
Fullerton, CA 92835
714-738-0800
714-738-3758 (fax)
Kellie_Simpson@sbcglobal.net
Alemtuzumab Clinical Trial in Multiple Sclerosis
Care-MSII At A Glance
- Alemtuzumab (IV) vs. High-Dose Interferon Beta-1a (SC)
- Adult patients 18-50 years of age
- Relapsing-remitting multiple sclerosis patients who have experienced >1MS attack (relapse) during treatment with interferon beta or glatiramer acetate after being on therapy for at least 6 months
- Patient will be randomized 2:2:1 to low-dose or interferon beta-1a
- Duration of study is between 2 and 4 years.
Study Rational
2-year results from an open-label, investigator-sponsored trial of alemtuzumab in 45 patients with active RRMS who had failed licensed beta-interferon therapy demonstrated:
- 70% of patients relapse-free after 2 years
- 0.38 decrease in EDSS score compared to baseline
- Annualized relapse rate decreased from 1.6 for the 2 years prior to treatment to 0.17 for the 2 years following treatment.
- The majority of treatment-related adverse events were mild to moderate
- Several patients experienced thyroid-related adverse events
For more information about the CARE-MS II clinical research study or to find out if you may be eligible to participate visit http://www.care-ms.com/ or call toll-free 1-888-408-MS-CARE. You can also contact Sheraz Mossa CCRC At: Neurology Center of North Orange County, phone 714-879-7200. Our web site is http://www.neurologyoc.com/.