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

NCT ID: NCT02254304

Last Updated: 2018-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-08-20

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 isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).

Conditions

Relapsing Multiple Sclerosis; Clinically Isolated Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rebif in Relapsing Multiple Sclerosis (RMS) Subjects

Group Type: EXPERIMENTAL

Rebif

Intervention Type: DRUG

Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.

Rebif in Clinically Isolated Syndromes (CIS) Subjects

Group Type: EXPERIMENTAL

Rebif

Intervention Type: DRUG

Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.

Interventions

Rebif

Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.

Intervention Type: DRUG

Other Intervention Names

Interferon beta-1a

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany

UNKNOWN

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Please contact the Merck KGaA Communication Center

Darmstadt, , Germany

Countries

Germany

Other Identifiers

2014-001290-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

200136-583

Identifier Type: -

Identifier Source: org_study_id