A condition in which the body's immune system mistakenly attacks its own tissue
The long, threadlike part of a neuron, or nerve cell, along which nerve signals are conducted
A term used to describe the brain and the spinal cord; the part of the body affected by multiple sclerosis
A clear fluid that circulates in the space surrounding the brain and spinal cord
A first neurologic episode that lasts at least 24 hours and is caused by inflammation/demyelination in 1 or more sites in the central nervous system
A degenerative process that erodes away the myelin sheath that normally protects nerve fibers. Demyelination exposes these fibers and appears to cause problems in nerve impulse conduction that may affect many physical systems
A strict method of conducting a clinical study that helps reduce the possibility of bias (unfair influence). In this type of study, health care providers and participants are “blinded,” meaning neither group knows what drug regimen each participant is taking
A testing method that measures electrical activity in the central nervous system
One of the most widely used rating systems for determining the ability level of people with RRMS. The EDSS measures changes in a person's physical ability in one-half step increments on a scale beginning with 0.0 and worsening to a level of 10.0. People with an EDSS level of 0.0 to 5.0 were included in the pivotal studies. Here are some of the scores from the EDSS and what they represent:
EDSS (up to 6.0)7
6.0 = Assistance needed to walk (single cane, crutch, or brace)
2.0-5.5 = Able to walk without assistance (various levels of disability present)
1.0-1.5 = No disability (some abnormal signs on the neurological exam)
0.0 = Normal neurological exam
One of the most complex biological systems, made up of an advanced network of cells, tissues, and organs that work together to provide the body with a natural system of defenses
The body's response to physical insult or injury resulting in increased blood flow with swelling, tenderness, redness, and/or heat
The measurement(s) taken during the last follow-up with a participant in a study
In multiple sclerosis, a damaged area in the brain or spinal cord caused by demyelination (also called plaque or sclerosis)
A diagnostic procedure employing a special scanner to obtain detailed images of a specific area of the body, such as the brain or spinal cord. Two scans traditionally used are T1 (sometimes also reported as gadolinium enhanced, GD) and T2. T1 can use a dye that allows the MRI to show areas of active inflammation. T2 images are helpful in providing information about disease burden or lesion load2
A clinical study that takes place at more than 1 medical center or clinic. Potential benefits of multicenter studies include a larger number of participants, different geographic locations, inclusion of various ethnic groups, and the ability to compare results among different medical centers—all of which help remove bias from the study
A disease that attacks the central nervous system. With MS, the immune system creates swelling and causes damage to the nerve coating (called myelin) that protects the nerve fibers in the brain and spinal cord. This damage prevents nerve cells from communicating properly to relay signals to and from other parts of the body
A soft, white coating that surrounds and protects nerve fibers in the central and peripheral nervous systems. Myelin also helps nerve fibers conduct electrical impulses
A medical doctor (or physician) who specializes in conditions that affect the nervous system, such as multiple sclerosis, epilepsy, or Parkinson's disease
The basic nerve cell of the central nervous system
Before launching a larger-scale clinical study, a pilot study may be conducted to ensure that the logistics, management, methods, and ideas behind an area of research is feasible. Pilot studies can also be used to test different dosages of, modes of administration for, and levels of compliance with a therapy
A controlled study to evaluate the safety and effectiveness of a drug in people who have the disease or condition to be treated. These studies usually represent the most rigorous demonstration of the drug's effectiveness and safety, and are the basis for filing with the FDA for approval to treat the disease
An inactive substance that looks like the active drug and helps determine the effectiveness of a drug by providing a basis for comparison
This study method compares participants taking a drug with participants taking placebo
The main goal of a clinical study. This goal must be met in order for the study to be considered successful
A method of conducting a clinical study in which participants are randomly chosen to take either one drug regimen or another. This method reduces the bias that can negatively affect the validity of medical research
A worsening of MS symptoms or an appearance of new symptoms (also called attack, exacerbation, or flare-up)
The most common form of MS, affecting approximately 85% of all newly diagnosed people. RRMS is characterized by relapses that are usually followed by partial or complete recovery
Relapsing forms of MS are considered to be inclusive of relapsing-remitting MS (RRMS) and clinically isolated syndrome (CIS). RRMS is the most common form of MS, affecting approximately 85% of all newly diagnosed people. RRMS is characterized by relapses that are usually followed by partial or complete recovery. CIS is a first neurologic episode that lasts at least 24 hours and is caused by inflammation/demyelination in 1 or more sites in the central nervous system.
Hardening of tissue. In MS, sclerosis is the body's replacement of lost myelin around central nervous system cells with scar tissue (also called lesion or plaque). The plural of this word is “scleroses”
Other important goals for measuring a treatment's effectiveness or safety in a clinical study
An injection with a shorter needle given into the fatty layer just under the skin
One type of protective white blood cell that travels throughout the bloodstream looking for viruses, bacteria, fungal infections, and tumor cells. T cells play an important role in protecting the body
