At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 260 enrolled
Drug / intervention
Interferon-beta-1a FBS-free/HSA-freebiological
Likely dose
Interferon-beta-1a 44 mcg subcutaneous 3 times per weekAI-extracted
Key inclusion· 6
- ✓Relapsing form of MS diagnosed according to McDonald criteria
- ✓Age 18–60 years
- ✓EDSS score <6.0
- ✓Eligible for interferon therapy
Key exclusion· 11
- ✕Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without relapses
- ✕Prior interferon-beta therapy (beta-1a or beta-1b)
- ✕Active MS relapse at study entry
- ✕Other approved MS disease-modifying therapy within 3 months prior to SD1 (e.g. glatiramer acetate, cytokine/anti-cytokine therapies)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating Interferon-beta-1a FBS-free/HSA-free for Multiple Sclerosis. Completed, enrolled 260 participants across 1 site.
Detailed Summary
The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
CollaboratorsPfizer
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
First PostedMay 2005
Primary CompletionApr 2007
TodayJul 2026
First PostedMay 9, 2005
Enrollment StartJan 1, 2005
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 21.1 years ago
Interventions
Interferon-beta-1a FBS-free/HSA-freebiological
Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.