CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 106 enrolled
Drug / intervention
Rebifdrug
Likely dose
Rebif 44 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02254304
NCT02254304Phase 4Completed
CompareCT.gov

Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™

Merck KGaA, Darmstadt, Germany·interventional·Posted Oct 1, 2014·Updated Mar 30, 2018

In Brief

A Phase 4 clinical trial evaluating Rebif for Relapsing Multiple Sclerosis and Clinically Isolated Syndrome. Completed, enrolled 106 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis, Clinically Isolated Syndrome
CountriesGermany
CollaboratorsMerck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 1, 2014
Enrollment StartDec 31, 2014
Primary CompletionAug 20, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.8 years ago

Interventions

Rebifdrug

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.