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

NCT02254304 | Completed Phase 4 Results

• 2 other identifiers: 200136-5832014-001290-14
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Keywords

Relapsing multiple sclerosis; Clinically isolated syndrome; RMS; CIS; RebiSmart™; Rebif®; Interferon beta-1a

Outcome Measures

Primary Outcomes (2)

• Percentage of Relapse-free RMS Subjects

  A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for "Rebif in RMS Subjects" arm.

  Month 12

• Time to the First Relapse for CIS Subjects

  A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for "Rebif in CIS Subjects" arm.

  Baseline up to 12 months

Secondary Outcomes (28)

• Percentage of Subjects With Treatment Adherence

  Month 12

• Percentage of Subjects With Relapse by Adherence Category

  Month 12

• Percentage of Subjects Who Prematurely Terminated Treatment and Reasons

  Baseline up to 12 months

• Percentage of Subjects Free From Clinical Disease Activity

  Baseline up to 12 months

• Percentage of Subjects Free From Disability Progression

  Baseline up to 12 months

Study Arms (2)

Rebif in Relapsing Multiple Sclerosis (RMS) Subjects

EXPERIMENTAL

Drug: Rebif

Rebif in Clinically Isolated Syndromes (CIS) Subjects

EXPERIMENTAL

Drug: Rebif

Interventions

Rebif 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.

Also known as: Interferon beta-1a

Rebif in Clinically Isolated Syndromes (CIS) Subjects; Rebif in Relapsing Multiple Sclerosis (RMS) Subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Please contact the Merck KGaA Communication Center

Darmstadt, Germany

Location

MeSH Terms

Interventions

Interferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: December 31, 2014
• Primary Completion: August 20, 2016
• Study Completion: August 20, 2016
• Last Updated: March 30, 2018
• Results First Posted: March 30, 2018

Record last verified: 2018-03

Locations

DE (1)