PROCEED
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
Percentage of Relapse-free RMS Subjects
Month 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Rebif In RMS Subjects | 66.3 percentage of subjects | 89 |
Time to the First Relapse for CIS Subjects
Baseline up to 12 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Rebif in CIS Subjects | Not reached | 17 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Rebif | 106 | 1 (0.9%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Relapse-free RMS Subjects
Month 12
RelapsesTime to the First Relapse for CIS Subjects
Baseline up to 12 months
RelapsesProportion of patients relapse free at 12 months of treatment at RMS subjects or time until the first relapse for CIS subjects.
Relapses
Other measures (29)
Percentage of Subjects With Treatment Adherence
Month 12
Quality of life (reported by participants)Percentage of Subjects With Relapse by Adherence Category
Month 12
RelapsesQuality of life (reported by participants)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
Disability progressionPercentage of Subjects Free From Disability Progression
Baseline up to 12 months
Disability progressionMean Number of Relapses in RMS Subjects
Month 12
RelapsesNumber of Subjects With Reasons of Missed Injections
Baseline up to 12 months
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Month 12
Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)
Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit
Month 12
Who could take part
Relapsing MS · 18 to 65
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
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History
Started
Dec 2014
Main results due
Aug 2016
Finished
Aug 2016
Results posted
Mar 2018
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