Cladribine Tablets as an Exit Therapy Strategy

NCT ID: NCT06887426

Last Updated: 2025-06-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-12-31

Brief Summary

The objective of the study is to evaluate the effectiveness of CladT, in terms of disease stability and safety, as the last treatment option in ageing MS patients vs treatment continuation and discontinuation This observational study will use database from local cohorts (from France, Belgium, Switzerland). Patients included must meet the inclusion criteria: RRMS diagnosis for more than 10 years without secondary progression, no evidence of disease activity (no relapse, no new MRI lesion, no EDSS progression) for more than 5 years under a DMT, age≥ 45-year-old.

Analyses will be using dynamic propensity score to match patients who stopped treatment with patients who had the same probability of continuing / stopping current treatments but took CladT as exit therapy. Patients with a minimum of 24 months follow up will be included.

The investigators will ensure that CladT provide disease stability compared to treatment continuation / discontinuation in ageing MS patients by measuring:

• the percentage of patients free of relapse, and time to first relapse, defined as the appearance, recurrence, or aggravation of neurological symptoms for a period of at least 24 hours without fever.
• the percentage of patients free of EDSS progression confirmed for at least 6 months and until the end of patient follow up.
• the percentage of patients free of MRI activity, defined as new or enlarged T2 lesions compared with the previous brain MRI scan or gadolinium enhancing T1 lesions.

Conditions

Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cladribine group

Cladribine

Intervention Type: DRUG

To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT

Continuing treatment group

No interventions assigned to this group

Interventions

Cladribine

To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient ≥45-year-old with RRMS
• Disease duration ≥10 years
• No evidence of disease activity ≥5 years under DMT
• EDSS score between 0 and 6.0 included

Exclusion Criteria

• Progressive form of MS
• Patients without DMT
• EDSS score ≥6.5

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de neurologie - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Facility Contacts

Jérôme DE SEZE

Role: primary

+ 33 3 88 12 85 43

Other Identifiers

9628

Identifier Type: -

Identifier Source: org_study_id