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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02254304
• Date of registration: 29/09/2014
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA, Darmstadt, Germany
• Public title: Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™ PROCEED
• Scientific title: Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™
• Date of first enrolment: December 31, 2014
• Target sample size: 106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02254304
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Germany

Contacts

• Name: Medical Responsible
• Affiliation: Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Clinically Isolated Syndrome

Relapsing Multiple Sclerosis

Intervention(s)

Drug: Rebif

Primary Outcome(s)

Time to the First Relapse for CIS Subjects [Time Frame: Baseline up to 12 months]

Percentage of Relapse-free RMS Subjects [Time Frame: Month 12]

Secondary Outcome(s)

Expanded Disability Status Scale (EDSS) Score [Time Frame: Baseline, Month 12]

Mean Number of Relapses in RMS Subjects [Time Frame: Month 12]

Percentage of Subjects Free From Clinical Disease Activity [Time Frame: Baseline up to 12 months]

Percentage of Subjects Who Prematurely Terminated Treatment and Reasons [Time Frame: Baseline up to 12 months]

Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS) [Time Frame: Month 12]

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 [Time Frame: Baseline up to 12 months]

Overall Evaluation of RebiSmart Use as Assessed by Investigator [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS) [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS) [Time Frame: Month 12]

Number of Subjects With Reasons of Missed Injections [Time Frame: Baseline up to 12 months]

Percentage of Subjects With Treatment Adherence [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS) [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS) [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS) [Time Frame: Month 12]

Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS) [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS) [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS). [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) [Time Frame: Month 12]

Body Mass Index (BMI) [Time Frame: Baseline, Month 12]

Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS). [Time Frame: Month 12]

Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS) [Time Frame: Month 12]

Percentage of Subjects Free From Disability Progression [Time Frame: Baseline up to 12 months]

Percentage of Subjects With Relapse by Adherence Category [Time Frame: Month 12]

Secondary ID(s)

200136-583

2014-001290-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

Results

• Results available: Yes
• Date Posted: 30/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02254304