NCT02254304

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Relapsing Multiple Sclerosis
• Clinically Isolated Syndrome

Interventions

Type	Name	Description
DRUG	Rebif	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.

Timeline

• Start date: 2014-12-31
• Primary completion: 2016-08-20
• Completion: 2016-08-20
• First posted: 2014-10-01
• Last updated: 2018-03-30
• Results posted: 2018-03-30

Locations

1 site across 1 country: Germany