Open-Label Natalizumab Safety Extension Study
An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803
What it found
We found no results in the registry or in papers.
This trial finished 21 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.
Month 24
SafetyThe primary objective of the study is to determine the safety and immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg IV to subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803.
Immune responseSafety
Other measures (1)
EDSS scores and assessments of relapse.
Month 24
Disability progressionRelapses
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Must give written informed consent. * Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803
Exclusion criteria
* History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment. * History of severe allergic or anaphylactic reactions or known drug hypersensitivity * A clinically significant infectious illness within 30 days prior to study entry.
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 determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.
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History
Started
Dec 2003
Main results due
Oct 2005
Finished
Jan 2006