NCT03250169

Brief Summary

Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
Last Updated

February 25, 2022

Status Verified

July 1, 2017

Enrollment Period

4.5 years

First QC Date

July 19, 2017

Last Update Submit

February 9, 2022

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Blood and CSF neurofilaments in Alemtuzumab patients over 24months

    Neurofilaments

    2 years

Secondary Outcomes (3)

  • Overall clinical response based on neurofilament response

    2 years

  • Neurofilament status and association with clinical and MRI markers of disease activity.

    2 years

  • Longitudinal assessment of other biomarkers of inflammation & plasticity

    2 years

Interventions

AlemtuzumabDRUG

Licensed dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Relapsing-remitting MS

You may qualify if:

  • Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
  • Age 18-55 years.
  • EDSS score between 0-5.5.
  • Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D

You may not qualify if:

  • A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
  • Those unable to comply with study requirement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University of London

London, England, E1 2AT, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

August 15, 2017

Study Start

August 1, 2017

Primary Completion

January 28, 2022

Study Completion

January 28, 2022

Last Updated

February 25, 2022

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)