A multicentre, single arm, open-label, phase IIIb study to evaluate th
A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis.
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
The primary endpoint is the proportion of subjects that are NAb positive at the Week 96 visit.
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: 1. Subject has a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria (31). Exclusion: 1. Subject has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of the study is to compare the antigenicity of the new FBS-free/HSA-free Rebif® formulation (RNF) to historical data
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History
Started
Dec 2004