Multiple Sclerosis: FutureMS-2 - an Observational Cohort and Scottish Precision Medicine Study
FutureMS-2: Clinical, Laboratory, and Genomic Predictors of Disease Activity in People Diagnosed With Relapsing Onset Multiple Sclerosis: an Observational Cohort and Scottish Precision Medicine Study
1 other identifier
observational
440
1 country
5
Brief Summary
FutureMS is a project created in direct response to frequent questions people with MS ask their doctors. Every person newly diagnosed wants to know how MS will affect them over their life and what can be done to stop the disease progressing and improve their quality of life. FutureMS aims to help answer those questions. The original FutureMS study provided a snapshot of the impact of MS within a year of diagnosis. However, MS is a long-term condition and so the investigators now want to better understand the impact of MS, on the same individuals, after approximately 5 and 10 years of living with MS. This is the purpose of FutureMS-2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2021
CompletedFirst Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
May 13, 2026
May 1, 2026
7.9 years
February 7, 2023
May 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease activity defined by new or enlarging T2 hyperintense lesion count on MR brain imaging at 5 years and 10 years of diagnosis with relapsing-remitting MS
Primary objective
at 5 and 10 years after diagnosis of relapsing - remitting MS
Secondary Outcomes (2)
Disease activity defined by the composite endpoint of new or enlarging T2 hyperintense lesions on MR brain imagingneurodegeneration and regenerative markers of disease activity
at 5 and 10 years after diagnosis of relapsing - remitting MS
clinical relapse at 5 and 10 years of diagnosis with relapsing-remitting MS
at 5 and 10 years after diagnosis of relapsing - remitting MS
Eligibility Criteria
The overwhelming majority (98%) of FutureMS participants have given consent to be approached for future research. The study aims to retain 90% of the consented FutureMS cohort. The majority of participants that took part in FutureMS gave their consent to be contacted about future ethically approved research. These participants will be contact directly by a phone, email or post by the study team.
You may qualify if:
- Previous participants in FutureMS cohort
- Capacity to provide informed consent
You may not qualify if:
- Not a participant of FutureMS inception cohort
- Contraindication to MR brain imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- NHS Lothiancollaborator
Study Sites (5)
Aberdeen Clinical Research Facility Royal Cornhill Hospital
Aberdeen, AB25 2ZD, United Kingdom
Dundee Clinical Research Centre Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Anne Rowling Regenerative Neurology Clinic
Edinburgh, EH16 4SB, United Kingdom
Glasgow Clinical Research Facility Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Centre for Health Sciences Raigmore Hospital
Inverness, IV2 3JH, United Kingdom
Related Publications (1)
Kearns PKA, Martin SJ, Chang J, Meijboom R, York EN, Chen Y, Weaver C, Stenson A, Hafezi K, Thomson S, Freyer E, Murphy L, Harroud A, Foley P, Hunt D, McLeod M, O'Riordan J, Carod-Artal FJ, MacDougall NJJ, Baranzini SE, Waldman AD, Connick P, Chandran S. FutureMS cohort profile: a Scottish multicentre inception cohort study of relapsing-remitting multiple sclerosis. BMJ Open. 2022 Jun 29;12(6):e058506. doi: 10.1136/bmjopen-2021-058506.
PMID: 35768080BACKGROUND
Biospecimen
plasma, serum, saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Siddharthan Chandran, Professor
University of Edinburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2023
First Posted
August 21, 2023
Study Start
October 7, 2021
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- After publication of study results, no end date.
- Access Criteria
- Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims of the proposal only. Data sharing request forms are available from future-ms@ed.ac.uk. Requesters will need to sign a data access agreement prior to being provided with access to data.
To ensure data transparency, the results of any closed comparisons will be published in a peer reviewed journal as soon as it is possible when the integrity of the study will not be affected. Individual level participant data will be shared, after de-identification, upon receipt of a valid request. Some data may be shared prior to the publication of study results depending on the requirements, however, no end point data will be released without explicit need. Each data request form will be individually reviewed to ensure the proposal has a valid rationale and appropriate methodology. Only data required for the project will be shared. A summary of results will be provided to all participants via newsletters and the Anne Rowling Clinic's website.