Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000769684
Ethics application status
Approved
Date submitted
25/11/2005
Date registered
30/11/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 220 0
Protocol Number 101-MS-321
Secondary ID [2] 221 0
EDRACT Number 2005-004061-41
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 925 0
Condition category
Condition code
Neurological 993 993 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All study subjects will receive up to 13 IV infusions (1 every 4 weeks) of natalizumab
Intervention code [1] 773 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1320 0
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
Timepoint [1] 1320 0
The objective will be analysed at the end of the study by looking at the data from when subjects completed the study.
Primary outcome [2] 1321 0
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.
Timepoint [2] 1321 0
The objective will be analysed at the end of the study by looking at the data from when subjects completed the study.
Secondary outcome [1] 2360 0
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.
Timepoint [1] 2360 0
Secondary outcome [2] 2361 0
ii) whether serial blood testing can be used for monitoring the presence of JCV in the MS population
Timepoint [2] 2361 0
Secondary outcome [3] 2362 0
iii) an approach to testing for persistent anti-natalizumab antibodies.
Timepoint [3] 2362 0

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment outside Australia
Country [1] 246 0
United Kingdom
State/province [1] 246 0

Funding & Sponsors
Funding source category [1] 1089 0
Commercial sector/Industry
Name [1] 1089 0
Biogen Idec
Country [1] 1089 0
United States of America
Funding source category [2] 1090 0
Commercial sector/Industry
Name [2] 1090 0
Elan Pharmaceuticals
Country [2] 1090 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Biogen Idec
Address
Country
United States of America
Secondary sponsor category [1] 951 0
None
Name [1] 951 0
N/A
Address [1] 951 0
Country [1] 951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2392 0
Royal Melbourne Hospital, Private Medical Centre
Ethics committee address [1] 2392 0
Ethics committee country [1] 2392 0
Australia
Date submitted for ethics approval [1] 2392 0
Approval date [1] 2392 0
Ethics approval number [1] 2392 0
Ethics committee name [2] 2393 0
Austin Health, Department of Neurology
Ethics committee address [2] 2393 0
Ethics committee country [2] 2393 0
Australia
Date submitted for ethics approval [2] 2393 0
Approval date [2] 2393 0
Ethics approval number [2] 2393 0
Ethics committee name [3] 2394 0
Royal Prince Alfred Hospital, Department of Medicine
Ethics committee address [3] 2394 0
Ethics committee country [3] 2394 0
Australia
Date submitted for ethics approval [3] 2394 0
Approval date [3] 2394 0
Ethics approval number [3] 2394 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35243 0
Address 35243 0
Country 35243 0
Phone 35243 0
Fax 35243 0
Email 35243 0
Contact person for public queries
Name 9962 0
Bethan Jones
Address 9962 0
Biogen Idec
Thames House
Foundation Park
Maidenhead Berkshire SL6 3UD
Country 9962 0
United Kingdom
Phone 9962 0
+44 0 1628501029
Fax 9962 0
+44 0 1628501010
Email 9962 0
bethan.jones@biogenidec.com
Contact person for scientific queries
Name 890 0
Bethan Jones
Address 890 0
Biogen Idec
Thames House
Foundation Park
Maidenhead Berkshire SL6 3UD
Country 890 0
United Kingdom
Phone 890 0
+44 0 1628501029
Fax 890 0
+44 0 1628501010
Email 890 0
bethan.jones@biogenidec.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.