A safety study for patients with Relapsing Forms of Multiple Sclerosis
A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.
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
What it measured
Main measures
The primary endpoint of the open label study is the incidence of AEs and SAEs.
Safety
Other measures (1)
• Disability progression as determined by Expanded Disability Status Scale
Disability progression
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: 1. Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations. Exclusion: 1. Patients participating in STRATA who were in line with current Belgian reimbursement criteria when they started in one of the feeder studies (Affirm or Sentinel).
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 for this study is long-term safety (incidence and pattern of SAEs) in patients receiving natalizumab.
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History
Started
Sept 2014