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 Evaluation

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12605000769684
• Date of registration: 30/11/2005
• Primary sponsor: Commercial sector/Industry Biogen Idec
• Public title: 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 Evaluation
• Scientific title: 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 Evaluation
• Date of first enrolment: 23/03/2006
• Target sample size: 900
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12605000769684.aspx
• Study type: Interventional
• Study design: Nonrandomised trial Single group

Countries of recruitment

United Kingdom

Contacts

• Name: Bethan Jones

• Name: Bethan Jones

Key inclusion & exclusion criteria

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).

Age minimum: 0 Not stated
Age maximum: 0 Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

All study subjects will receive up to 13 IV infusions (1 every 4 weeks) of natalizumab

Primary Outcome(s)

The primary objective of this study is to further evaluate the safety of natalizumab monotherapy by:
i) evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab

The primary objective of this study is to further evaluate the safety of natalizumab monotherapy by:
ii) confirming the safety of switching from IFNb, GA, or other MS therapies to natalizumab.

Secondary Outcome(s)

i) the feasibility of a methodology for early detection and differentiation of PML from MS in subjects who develop new neurological symptoms or signs while on natalizumab therapy.

ii) whether serial blood testing can be used for monitoring the presence of JCV in the MS population

iii) an approach to testing for persistent anti-natalizumab antibodies.

Secondary ID(s)

EDRACT Number 2005-004061-41

Protocol Number 101-MS-321

Source(s) of Monetary Support

Elan Pharmaceuticals

Biogen Idec

Secondary Sponsor(s)

N/A