CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 232 enrolled
Drug / intervention
Rebif New Formulation Non Titrated +1 moredrug
Likely dose
Rebif New Formulation (RNF), human interferon beta-1a, either titrated or non-titrated regimenAI-extracted
Key inclusion· 7
  • ✓Relapsing form of multiple sclerosis diagnosed by McDonald criteria
  • ✓Currently taking Rebif 44 mcg three times weekly and has been on this dose for at least 6 months prior to enrollment
  • ✓Currently using Rebiject II and 29 gauge needle
  • ✓Age 18 to 60 years old
Key exclusion· 11
  • ✕Prior exposure to Rebif New Formulation (RNF)
  • ✕Progressive forms of multiple sclerosis
  • ✕History of chronic pain syndrome
  • ✕Concurrent MS therapy in addition to Rebif within 3 months prior to enrollment

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

Search/NCT00472797
NCT00472797Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)

EMD Serono·interventional·Posted May 14, 2007·Updated Aug 7, 2013

In Brief

A Phase 3 clinical trial evaluating Rebif New Formulation Non Titrated and Rebif New Formulation Titrated for Relapsing Multiple Sclerosis. Completed, enrolled 232 participants across 1 site.

Detailed Summary

To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 14, 2007
Enrollment StartApr 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.1 years ago

Interventions

Rebif New Formulation Non Titrateddrug

human interferon beta 1a - Rebif New Formulation

Rebif New Formulation Titrateddrug

Human interferon beta 1a Rebif New Formulation