Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
With
Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female subjects between 18 to 65 years of age
Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010)
Treatment-naive subjects or subjects treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit
Subjects that are able to self-inject with RebiSmart™ (in the opinion of the physician)
Subjects with Expanded Disability Status Scale (EDSS) score less than (\<) 6 (inclusive) at Baseline
Signed informed consent and subject data collection form
You may not be if
Subjects experiencing a relapse within 30 days before Baseline
Participation in other studies within 30 days before Baseline
Received any MS therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™
Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart™
Pregnancy and breast-feeding
Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion
Current or past (within the last 2 years) history of alcohol or drug abuse
Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics
