Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000455662
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
14/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
MSBase- An international Registry dedicated to evaluating outcomes data in Multiple Sclerosis
Scientific title
MSBase- An international Registry dedicated to evaluating outcomes data in Multiple Sclerosis
Universal Trial Number (UTN)
Trial acronym
MSBase
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 570 0
Condition category
Condition code
Neurological 646 646 0 0
Multiple sclerosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The MSBase study is an ongoing, observational registry tracking the natural history of Multiple Sclerosis in the long term. In collaboration with participating neurologists the MSBase Registry will establish a unique international database for tracking and evaluating outcomes data in MS.
Intervention code [1] 584 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 757 0
EDSS score
Timepoint [1] 757 0
Primary outcome [2] 758 0
Kurtzke Functional Score
Timepoint [2] 758 0
Primary outcome [3] 759 0
Relapse rate
Timepoint [3] 759 0
Primary outcome [4] 760 0
Treatment and/or hospital admission for relapse
Timepoint [4] 760 0
Primary outcome [5] 761 0
Commencement or cessation of disease modifying drugs
Timepoint [5] 761 0
Primary outcome [6] 762 0
MRI findings
Timepoint [6] 762 0
Secondary outcome [1] 1551 0
Time to second relapse (time to Clinically definite MS).
Timepoint [1] 1551 0

Eligibility
Key inclusion criteria
All patients with Clinically Isolated Syndromes/ First Demyelinating Events suggestive of MS and all patients with Multiple Sclerosis are eligible provided the neurologist maintains the standardised minimum dataset including annual assessment of the patients Expanded Disability Status Score.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 706 0
Other
Name [1] 706 0
Grants from private and public agencies
Country [1] 706 0
Primary sponsor type
Charities/Societies/Foundations
Name
MSBase Foundation Ltd
Address
Country
Australia
Secondary sponsor category [1] 591 0
None
Name [1] 591 0
Nil
Address [1] 591 0
Country [1] 591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1908 0
Royal Melbourne Hospital
Ethics committee address [1] 1908 0
Ethics committee country [1] 1908 0
Australia
Date submitted for ethics approval [1] 1908 0
Approval date [1] 1908 0
Ethics approval number [1] 1908 0
Ethics committee name [2] 1909 0
Box Hill Hospital
Ethics committee address [2] 1909 0
Ethics committee country [2] 1909 0
Australia
Date submitted for ethics approval [2] 1909 0
Approval date [2] 1909 0
Ethics approval number [2] 1909 0
Ethics committee name [3] 1910 0
St Vincent's Hospital
Ethics committee address [3] 1910 0
Ethics committee country [3] 1910 0
Australia
Date submitted for ethics approval [3] 1910 0
Approval date [3] 1910 0
Ethics approval number [3] 1910 0
Ethics committee name [4] 1911 0
John Hunter Hospital
Ethics committee address [4] 1911 0
Ethics committee country [4] 1911 0
Australia
Date submitted for ethics approval [4] 1911 0
Approval date [4] 1911 0
Ethics approval number [4] 1911 0

Summary
Brief summary
The MSBase Registry is a longitudinal, strictly observational Multiple Sclerosis database open to all practicing Neurologists worldwide. In collaboration with participating Neurologists, the MSBase Registry has established a unique, web-based platform dedicated to sharing, tracking and evaluating outcomes data in Multiple Sclerosis (MS). In particular, MSBase aims to advance multi-centre, multi-national epidemiological and outcomes research by providing a freely accessible resource to compile, combine, compare and analyse large datasets.
Participating Neurologists submit anonymized core clinical information using the freely available iMed software as a standardized data collection instrument. The core data to be collected is termed the minimum dataset, comprising key parameters relating to diagnosis, serial neurological examinations (Kurtzke Functional Score and Expanded Disability Status Score, EDSS), relapse information and treatment exposures. All aspects of patient management are entirely at the discretion of the managing neurologist and his or her patient.
Anonymized aggregate data generated from the MSBase Registry will be reported to participating Neurologists on a regular basis. Important findings will be shared with the general neurology community at scientific meetings and through journal publications.
The MSBase Scientific Advisory Board (SAB) acts as the custodian of the composite data, while individual datasets at all times remain the property of the participating physician. The MSBase SAB will ensure data integrity and monitor all MSBase activities including core study designs, promotion and implementation, and perform composite data analyses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35144 0
Address 35144 0
Country 35144 0
Phone 35144 0
Fax 35144 0
Email 35144 0
Contact person for public queries
Name 9773 0
Mrs Michelle Hoffmann
Address 9773 0
MSBase Foundation
Department of Neurology
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 9773 0
Australia
Phone 9773 0
+61 3 93428070
Fax 9773 0
+61 3 93428070
Email 9773 0
[email protected]
Contact person for scientific queries
Name 701 0
Mrs Michelle Hoffmann
Address 701 0
MSBase Foundation
Department of Neurology
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 701 0
Australia
Phone 701 0
+61 3 93428070
Fax 701 0
+61 3 93428070
Email 701 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbasePredictors of long-term disability accrual in relapse-onset multiple sclerosis.2016https://dx.doi.org/10.1002/ana.24682
EmbaseDefining secondary progressive multiple sclerosis.2016https://dx.doi.org/10.1093/brain/aww173
EmbaseAssociation of Inflammation and Disability Accrual in Patients with Progressive-Onset Multiple Sclerosis.2018https://dx.doi.org/10.1001/jamaneurol.2018.2109
EmbaseAnti-inflammatory disease-modifying treatment and short-term disability progression in SPMS.2017https://dx.doi.org/10.1212/WNL.0000000000004330
EmbaseTowards personalized therapy for multiple sclerosis: Prediction of individual treatment response.2017https://dx.doi.org/10.1093/brain/awx185
EmbaseLong-term outcomes in patients presenting with optic neuritis: Analyses of the MSBase registry.2021https://dx.doi.org/10.1016/j.jns.2021.118067
EmbaseThe MSBase pregnancy, neonatal outcomes, and women's health registry.2021https://dx.doi.org/10.1177/17562864211009104
EmbaseNatalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: A Subgroup Analysis From Three International Cohorts.2021https://dx.doi.org/10.1007/s40263-021-00860-7
EmbaseAssociation of Sustained Immunotherapy with Disability Outcomes in Patients with Active Secondary Progressive Multiple Sclerosis.2020https://dx.doi.org/10.1001/jamaneurol.2020.2453
EmbaseMultiple Sclerosis Severity Score (MSSS) improves the accuracy of individualized prediction in MS.2022https://dx.doi.org/10.1177/13524585221084577
EmbaseRisk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry.2022https://dx.doi.org/10.1111/ene.14824
EmbaseReal-world effectiveness of cladribine for Australian patients with multiple sclerosis: An MSBase registry substudy.2021https://dx.doi.org/10.1177/1352458520921087
EmbaseRates of John Cunningham virus seroconversion greatly reduced in natalizumab-treated patients during COVID-19-related lockdowns.2024https://dx.doi.org/10.1111/ene.16059
EmbaseVariability of the response to immunotherapy among subgroups of patients with multiple sclerosis.2023https://dx.doi.org/10.1111/ene.15706
EmbaseRisk of secondary progressive multiple sclerosis after early worsening of disability.2023https://dx.doi.org/10.1136/jnnp-2023-331748
Dimensions AIComparative effectiveness of cladribine tablets versus other oral disease-modifying treatments for multiple sclerosis: Results from MSBase registry2022https://doi.org/10.1177/13524585221137502
Dimensions AIHigh rates of JCV seroconversion in a large international cohort of natalizumab-treated patients2021https://doi.org/10.1177/1756286421998915
Dimensions AIHighly active immunomodulatory therapy ameliorates accumulation of disability in moderately advanced and advanced multiple sclerosis2016https://doi.org/10.1136/jnnp-2016-313976
Dimensions AIThe risk of secondary progressive multiple sclerosis is geographically determined but modifiable2023https://doi.org/10.1093/brain/awad218
Dimensions AIThe effect of oral immunomodulatory therapy on treatment uptake and persistence in multiple sclerosis2015https://doi.org/10.1177/1352458515594041
Dimensions AIEffects of High- and Low-Efficacy Therapy in Secondary Progressive Multiple Sclerosis2021https://doi.org/10.1212/wnl.0000000000012354
N.B. These documents automatically identified may not have been verified by the study sponsor.