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

• Status: Completed
• Trial end date: 2016-08-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

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