Overview

Natalizumab (Tysabri) Re-Initiation of Dosing

Status:
Terminated
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
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 immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Treatments:
Natalizumab
Criteria
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.