Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™

Launched by MERCK KGAA, DARMSTADT, GERMANY · Sep 29, 2014

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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