CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 97 enrolled
Drug / intervention
Rebif Rebidose +1 moredevice
Likely dose
Not stated in 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/NCT02019550
NCT02019550Phase 4Completed

A Phase IV, Randomized, Prospective, US-based, Multicenter, Cross-over Study Evaluating Subject Ease-of-use With Rebif® Rebidose® and Rebiject II® Autoinjectors in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With REBIF® 44 mcg Subcutaneously Three Times a Week

EMD Serono·interventional·Posted Dec 24, 2013·Updated Mar 7, 2017

In Brief

A Phase 4 clinical trial evaluating Rebif Rebidose and Rebiject II for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 97 participants across 21 sites.

Detailed Summary

This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up to 10 weeks (including screening and treatment periods). The treatment period will last 8 weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections using the Rebiject II® device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 24, 2013
Enrollment StartMar 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.5 years ago

Interventions

Rebif Rebidosedevice

Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.

Rebiject IIdevice

Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.