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|
|Actual Primary Completion Date :||April 2007|
|Actual 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|