Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

Treatment efficacy
The proportion of patients with ne evidence of disease activity-3 (NEDA-3) as defined by: no clinical relapse, no disability progression, no radiological disease activity.
2 years

Secondary Outcomes (20)

Annual relapse rate
2 years
Time to first relapse
2 years
Confirmed disability progression (CDP)
2 years
Confirmed disability improvement (CDI)
2 years
Progression independent of relapse activity (PIRA)
2 years
+15 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with highly active relapsing-remitting multiple sclerosis are eligible for treatment with aHSCT in the Netherlands if they meet the criteria as defined by the Dutch National Health Care Institute.

You may qualify if:

All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS

Sponsors & Collaborators

St. Antonius Hospital
Othercollaborator
Amsterdam UMC, location VUmc
Otherlead

Study Sites (2)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Rick Heijnen, MScCONTACT+31627228507 r.m.heijnen@amsterdamumc.nl

R.M. Heijnen, MScSUB INVESTIGATOR

Z.L.E. Van Kempen, MSc, PhDSUB INVESTIGATOR

J. Killestein, MSc, PhDPRINCIPAL INVESTIGATOR

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

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 Officials

J. Killestein, MSc, PhD
Amsterdam UMC
PRINCIPAL INVESTIGATOR

Central Study Contacts

Rick Heijnen, MSc

CONTACT

+31627228507 r.m.heijnen@amsterdamumc.nl

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 5 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinical Professor

Study Record Dates

First Submitted

June 25, 2024

First Posted

August 22, 2024

Study Start

August 25, 2023

Actual (reported)

Primary Completion

September 1, 2028

Estimated

Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations