Phase 4
Completed N=106
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
Source: ClinicalTrials.gov NCT02254304 ↗Enrolled (actual)
106
Serious AEs
0.9%
Results posted
Mar 2018
Primary outcomePrimary: Percentage of Relapse-free RMS Subjects — 66.3 percentage of subjects
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Relapse-free RMS Subjects |
66.3 | — |
| PRIMARY Time to the First Relapse for CIS Subjects |
NA | — |
| SECONDARY Percentage of Subjects With Treatment Adherence |
2.2; 11.8; 2.2; 0.0; 13.5; 0.0 | — |
| SECONDARY Percentage of Subjects With Relapse by Adherence Category |
0.0; 0.0; 0.0; 16.7; 19.4; 6.7 | — |
| SECONDARY Percentage of Subjects Who Prematurely Terminated Treatment and Reasons |
2.2; 5.9; 2.2; 11.8; 1.1; 0.0 | — |
| SECONDARY Percentage of Subjects Free From Clinical Disease Activity |
— | — |
| SECONDARY Percentage of Subjects Free From Disability Progression |
— | — |
| SECONDARY Mean Number of Relapses in RMS Subjects |
0.2 | — |
| SECONDARY Number of Subjects With Reasons of Missed Injections |
48; 23; 11; 5; 5; 4 | — |
| SECONDARY Overall Evaluation of RebiSmart Use as Assessed by Investigator |
46; 13; 32; 1; 9; 1 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS) |
0.2; 0.1 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit |
1; 1; 15; 0 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home |
0.0; 0.0 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS) |
0.0; 0.0 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS) |
0.1; 0.0 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS) |
2; 1 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS) |
2.5; 2.0 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS) |
2.0; 4.0 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS) |
1; 1 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS) |
1; 3 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS). |
2; 2 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects |
46.5; 3.5 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS). |
1; 2 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects |
8.0; 3.0 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS) |
7; 1 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score |
23; 3; 45; 6; 21; 8 | — |
| SECONDARY 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 |
30; 1; 0; 4 | — |
| SECONDARY Expanded Disability Status Scale (EDSS) Score |
1.87; 1.24; 1.80; 1.13 | — |
| SECONDARY Body Mass Index (BMI) |
23.57; 23.51 | — |
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
Data sourced from ClinicalTrials.gov (NCT02254304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.