Status:
COMPLETED
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02254304
Start Date
December 31 2014
End Date
August 20 2016
Last Update
March 30 2018
Active Locations (1)
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1
Please contact the Merck KGaA Communication Center
Darmstadt, Germany