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Cladribine Tablets as an Exit Therapy Strategy

Cladribine Tablets as an Exit Therapy Strategy: Alternative to Continuing Treatment and Plain Treatment Discontinuation in Ageing Stable RMS Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06887426
Acronym
CLADREXIT
Enrollment
450
Registered
2025-03-20
Start date
2025-06-30
Completion date
2025-12-31
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

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.

Interventions

DRUGCladribine

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

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT2 yearsProportion of patients with relapses\* and time to event during the 2 years of follow-up in patients switching to cladribine and continuing current DMT

Secondary

MeasureTime frameDescription
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and stopping current DMT2 yearsProportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and stopping current DMT
To evaluate the clinical activity during the 3 years of follow-up in patients switching to cladribine and continuing current DMT2 yearsProportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and continuing current DMT
To evaluate the radiological activity during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT2 yearsProportion of patients with new T2 lesions on brain MRI at 1 and 2 years in patients switching to cladribine, continuing current DMT and stopping DMT
To evaluate the disability during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT2 yearsProportion of patients with EDSS worsening\*\* after 2 years in patients switching to cladribine, continuing current DMT and stopping DMT
To evaluate the risk of serious adverse events in patients switching to cladribine and continuing current DMT2 yearsProportion of patients with any serious adverse events after 2 years in patients switching to cladribine and continuing current DMT

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026