CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
Rebif® +1 moredrug
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/NCT02064816
NCT02064816Phase 4Completed

Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis

Merck KGaA, Darmstadt, Germany·interventional·Posted Feb 17, 2014·Updated Sep 20, 2018

In Brief

A Phase 4 clinical trial evaluating Rebif® for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 200 participants across 1 site.

Detailed Summary

This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in subjects with relapsing multiple sclerosis (RMS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2014
Enrollment StartMay 31, 2014
Primary CompletionApr 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.4 years ago

Interventions

Rebif®drug

Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week in the morning using RebiSmart® self-injector device for 12 weeks.

Rebif®drug

Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week in the evening using RebiSmart® self-injector device for 12 weeks.