Status:
TERMINATED
Natalizumab (Tysabri) Re-Initiation of Dosing
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenic...
Detailed Description
Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab in former clinical trial participants in Studies C-1801 (NCT00027300...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study
- Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study.
- In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480).
- Key Exclusion Criteria
- Considered by the Investigator to be immunocompromised
- History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
- History of any major disease or malignancy
- Discontinued natalizumab in a previous study due to allergic reaction
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1094 Patients enrolled
Trial Details
Trial ID
NCT00297232
Start Date
March 1 2006
End Date
April 1 2014
Last Update
July 15 2016
Active Locations (112)
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1
Research Site
Camperdown, Australia, 2050
2
Research Site
Heidelberg, Australia, 3084
3
Research Site
Parkville, Australia, 3050
4
Research Site
Bruges, Belgium, 8000