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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Relapsing Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Drug: Rebif

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02254304

200136-583

2014-001290-14 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 106 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Rebif in Relapsing Multiple Sclerosis (RMS) Subjects

Experimental group

Treatment:

Drug: Rebif

Rebif in Clinically Isolated Syndromes (CIS) Subjects

Experimental group

Treatment:

Drug: Rebif