A multicenter, randomized, rater-blind study to compare the efficacy a
A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
The primary endpoint of this study is to compare the effect of natalizumab with IFN beta-1a on:
Who could take part
Relapsing MS · EDSS 0.0 to 5.5
Show the full criteria
Inclusion criteria
Inclusion: Male and female subjects between 18 and 55 years of age who have a diagnosis of multiple sclerosis (MS) as defined by McDonald et al., criteria #1-4 (McDonald et al., 2001, Section 22), and a baseline EDSS score between 0.0 and 5.5, inclusive. Exclusion: Primary progressive, secondary progressive, or progressive relapsing MS.
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 this study is to compare the effect of natalizumab with IFN beta-1a on the annualized rate of clinical relapses at 1 year.
Papers
Loading reviews and guidelines…
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History
Started
Jan 2005