NCT05446285

Brief Summary

To provide real world evidence evaluating whether a strategy of early initiation and escalation of disease modifying treatment (DMT) in relapsing-remitting multiple sclerosis (RRMS) affects disease outcome over a 10 year period. Our aim is to provide evidence for clinicians and patients regarding the benefits and risks of early initiation and active escalation of disease modifying treatments (DMTs) in relapsing-remitting multiple sclerosis (RRMS), using real world data.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

February 7, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

June 30, 2022

Last Update Submit

July 20, 2022

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Mean Expanded Disability Status Scale (EDSS) score at prospective assessment.

    EDSS scores range from 0-10. The higher the score the worse the level of disability.

    Single visit assessment competed by Dec 2022

Secondary Outcomes (6)

  • Proportion experiencing (serious) adverse events in first 9-10 years after diagnosis

    Single visit assessment competed by Dec 2022

  • Proportion attaining Expanded Disability Status Scale (EDSS) 3.0, 4.0 and 6.0

    Single visit assessment competed by Dec 2022

  • Mean change in Expanded Disability Status Scale (EDSS) between treatment groups

    Single visit assessment competed by Dec 2022

  • Mean scores on patient reported outcome measure Multiple Sclerosis Impact Scale -29 (MSIS-29) at prospective assessment

    Single visit assessment competed by Dec 2022

  • Mean Brief International Cognitive Assessment for MS (BICAMS) score at prospective assessment

    Single visit assessment competed by Dec 2022

  • +1 more secondary outcomes

Other Outcomes (3)

  • Mean scores on patient reported outcome measures (PROMs)

    Single visit assessment competed by Dec 2022

  • Mean volume of grey matter and whole brain volume on prospective MRI scans

    Single visit assessment competed by Dec 2022

  • Mean lesion volume of T2/FLAIR on prospective MRI scans

    Single visit assessment competed by Dec 2022

Study Arms (2)

Treated

Patients initiating disease modifying treatment within the first year of diagnosis

Other: Clinical assessment

Untreated

Patients who do not initiate disease modifying treatment within the first year of diagnosis

Other: Clinical assessment

Interventions

Clinical assessmentOTHER

All participants will be invited to attend their local research facility to undergo a physical and questionnaire assessment as well as an MRI. Assessments include: Expanded Disability Status Scale, 9-Hole Peg Test, MRI scan, Patient Reported Outcome Measures (MSIS-29, neuroQOL and PROMIS), Brief International Cognitive Assessment for MS)

TreatedUntreated

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As above, Patients diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) in 2010-11 in Scotland, as held on the Scottish Multiple Sclerosis Register

You may qualify if:

  • Patients diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) in 2010-11 in Scotland, as held on the Scottish Multiple Sclerosis Register

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Facility

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 6, 2022

Study Start

February 7, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)