Clinical trial NCT02254304: Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
Official title: Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Keywords: Relapsing multiple sclerosis
Clinically isolated syndrome
RMS
CIS
RebiSmart™
Rebif®
Interferon beta-1a
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany
First posted: 2014-10-01
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Relapse-free RMS Subjects
timeFrame: Month 12
measure: Time to the First Relapse for CIS Subjects
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Percentage of Subjects With Treatment Adherence
timeFrame: Month 12
measure: Percentage of Subjects With Relapse by Adherence Category
timeFrame: Month 12
measure: Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
timeFrame: Baseline up to 12 months
measure: Percentage of Subjects Free From Clinical Disease Activity
timeFrame: Baseline up to 12 months
measure: Percentage of Subjects Free From Disability Progression
timeFrame: Baseline up to 12 months
measure: Mean Number of Relapses in RMS Subjects
timeFrame: Month 12
measure: Number of Subjects With Reasons of Missed Injections
timeFrame: Baseline up to 12 months
measure: Overall Evaluation of RebiSmart Use as Assessed by Investigator
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS).
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS).
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
timeFrame: Month 12
measure: Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score
timeFrame: Month 12
measure: Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination
timeFrame: Baseline up to 12 months
measure: Expanded Disability Status Scale (EDSS) Score
timeFrame: Baseline, Month 12
measure: Body Mass Index (BMI)
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: