Status:
COMPLETED
Natalizumab Re-Initiation of Dosing
Lead Sponsor:
Biogen
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to nat...
Detailed Description
Study 101-MS-322 (NCT00306592) is conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial participants in Studies C-1801 (NCT00027300)...
Eligibility Criteria
Inclusion
- MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging \[MRI\] scan)
- Considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 \[NCT000276172\] may be used)
- Other protocol-defined inclusion criteria may apply
Exclusion
- Considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment
- History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00306592
Start Date
March 1 2006
End Date
February 1 2008
Last Update
March 21 2017
Active Locations (63)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Phoenix, Arizona, United States, 85006
3
Research Site
Scottsdale, Arizona, United States, 85259
4
Research Site
Little Rock, Arkansas, United States, 72205