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Clinical Studies
What is a clinical study?
A clinical study is a medical trial that is carried out in order to answer specific questions about new treatments or new ways of using known treatments. Well-conducted clinical trials help researchers find treatments that work well.
There are rules and ethical standards that help protect the rights and safety of people who take part in these studies. Drugs are usually first tested in the laboratory before they are used in humans.
Why are clinical trials important?
Prescription drugs must go through the US Food and Drug Administration (FDA) approval process before they are allowed to enter the market. Well-designed clinical trials follow scientific rules to find out whether a drug is safe and effective— the 2 conditions that must be met before a drug is approved. Drug makers work closely with the FDA before beginning clinical trials.
The BETASERON pivotal trial
The BETASERON pivotal trial (the key trial for the FDA approval of BETASERON) was a large, placebo-controlled study. As a result of this trial, in 1993 BETASERON was the first approved drug for relapsing forms of multiple sclerosis (MS). Since then, tens of thousands of people with MS have benefited from BETASERON.
Learn more about the BENEFIT Study, a clinical trial for people who experienced a first MS event. Go>
The BETASERON Long-term Follow-up Study covers more than 17 years of scientific data. Learn more
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BETASERON® (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
Important Safety Information
The most commonly reported adverse reactions are lymphopenia, injection-site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. BETASERON should be used with caution in patients with depression. Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information.
