An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluatio

Phase 3

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12605000769684
• Lead Sponsor: Biogen Idec

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Must be an MS subject who completed Study C-1801 or C-1802 and completed a Dosing Suspension Safety Evaluation (neurological examination and an MRI scan); must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used); must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNb and GA) for the duration of the study.

Exclusion Criteria

Considered by the Investigator to be immunocompromised or have a history of organ transplant; history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies; history of severe allergic or anaphylactic reactions or known drug hypersensitivity; discontinued natalizumab in a previous study due to allergic reaction or any other SAE considered to be related to natalizumab treatment; discontinued study drug in Study C-1801 or C-1802 because of an AE or due to reasons other than significant disease progression (as defined in the C-1801 and C-1802 protocols).

Study & Design

• Study Type: Interventional
• Study Design: Not specified