At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 109 enrolled
Drug / intervention
Rebidose®device
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.
A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of a Ready-to-use, Single-use Autoinjector (SA) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc), Three Times a Week (Tiw)
In Brief
A Phase 3 clinical trial evaluating Rebidose® for Multiple Sclerosis. Completed, enrolled 109 participants across 1 site.
Detailed Summary
The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartOct 2009
Primary CompletionApr 2010
Study CompletionJun 2010
TodayJul 2026
First PostedAug 13, 2009
Enrollment StartOct 1, 2009
Primary CompletionApr 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.9 years ago
Interventions
Rebidose®device
The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection