Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06887426

Cladribine Tablets as an Exit Therapy Strategy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cladribine

Drug

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

Primary outcomes

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

    Time frame: 2 years

    Proportion 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 outcomes

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

    Time frame: 2 years

    Proportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and stopping current DMT

  2. To evaluate the clinical activity during the 3 years of follow-up in patients switching to cladribine and continuing current DMT

    Time frame: 2 years

    Proportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and continuing current DMT

  3. To evaluate the radiological activity during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT

    Time frame: 2 years

    Proportion 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

  4. To evaluate the disability during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT

    Time frame: 2 years

    Proportion of patients with EDSS worsening** after 2 years in patients switching to cladribine, continuing current DMT and stopping DMT

  5. To evaluate the risk of serious adverse events in patients switching to cladribine and continuing current DMT

    Time frame: 2 years

    Proportion of patients with any serious adverse events after 2 years in patients switching to cladribine and continuing current DMT

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: CLADREXIT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Jun 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.