Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis (RNF)
|ClinicalTrials.gov Identifier: NCT00110396|
Recruitment Status : Completed
First Posted : May 9, 2005
Results First Posted : July 9, 2010
Last Update Posted : July 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Biological: Interferon-beta-1a FBS-free/HSA-free||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2005|
|Primary Completion Date :||April 2007|
|Study Completion Date :||April 2007|
|Experimental: Rebif New Formulation Cohort||
Biological: Interferon-beta-1a FBS-free/HSA-free
Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
- Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit. [ Time Frame: 96 weeks ]The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
- Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study [ Time Frame: 96 weeks ]The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
- Number of Participants With Binding Antibodies (BAb) at Week 96 [ Time Frame: 96 weeks ]Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110396
|United States, Massachusetts|
|Local US Medical Information|
|Rockland, Massachusetts, United States, 02370|
|Study Director:||Bettina Stubinski, MD||Merck Serono SA - Geneva|