NCT07313462

Brief Summary

The objective of this study is to evaluate the risk of inflammatory disease activity by retrospectively comparing two therapeutic strategies (escalation group and induction group). The investigators also aim to identify factors associated with inflammatory relapse and treatment-related complications.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

Multiple Sclerosis (MS)Escalation TherapyInduction Therapy

Outcome Measures

Primary Outcomes (1)

  • Time to First Clinical Inflammatory Relapse

    Compare the time to first clinical inflammatory relapse between two groups of patients who developed relapsing-remitting MS (RRMS) after age 50: * Group 1 = therapeutic escalation strategy: starting with a moderately effective treatment (teriflunomide, dimethyl fumarate or diroximel fumarate, glatiramer acetate, interferon beta, peginterferon) * Group 2 = induction strategy: starting with a highly effective treatment (fingolimod, ponesimod, natalizumab, rituximab, ocrelizumab, ofatumumab, cladribine)

    Up to 12 months

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with RRMS onset after age 50

You may qualify if:

  • Patients with RRMS onset after age 50
  • Patients who started their first disease-modifying therapy within 2 years of the first symptoms
  • Patients Treated with moderately effective disease-modifying antirheumatic drugs (DMARDs) (teriflunomide, dimethyl fumarate or diroximel fumarate, glatiramer acetate, interferon beta, peginterferon)
  • Patient treated with highly effective DMARDs (fingolimod, ponesimod, natalizumab, rituximab, ocrelizumab, ofatumumab, cladribine)

You may not qualify if:

  • \- Patients with early progressive MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 2, 2026

Study Start

February 7, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations