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CompletedNCT06887426CLADREXITUpdated Oct 6, 2026

Cladribine Tablets as an Exit Therapy Strategy

An observational study in Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by University Hospital, Strasbourg, France · Observational

Updated Oct 6, 2026Now CompletedStart date moved+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
450
Ages
45 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Multiple Sclerosis
  • Relapsing Remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's enrollment of 450 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This is a multicentric retrospective and controlled cohort with non-inferiority analysis. Patients will be matched 1:1 using propensity score on gender, age, MS duration, time before last relapse, EDSS score, DMTs.

The study will use retrospectively collected data within the date frame from 06/30/25 to 06/30/26.

Approximately 150 patients treated with cladribine will be identified and included in this study in 7 centers: Strasbourg, Lille, Montpellier, Nimes, Liège, Pelt, Lugano.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Progressive form of MS
  • Patients without DMT
  • EDSS score ≥6.5
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
450 participants (actual)
Patient registry
No

Groups and cohorts

  • Cladribine group

    Drug: Cladribine

  • Continuing treatment group

Interventions

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

06

What researchers measure

Primary outcomes

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

    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

    Time frame: 2 years

Secondary outcomes

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

    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

    Time frame: 2 years

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

    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

    Time frame: 2 years

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

    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

    Time frame: 2 years

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

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

    Time frame: 2 years

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

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

    Time frame: 2 years

07

Study locations

1 site
  • Service de neurologie - Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Oct 6, 2026
Start date
Jun 2025→Oct 17, 2025 (actual)
Oct 6, 2026
Primary completion
Dec 2025→Jun 1, 2026 (actual)
Oct 6, 2026
Study completion
Dec 2025→Jun 1, 2026 (actual)
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Completed
    Start date Jun 2025→Oct 17, 2025 (now actual)
    Primary completion Dec 2025→Jun 1, 2026 (now actual)
    Study completion Dec 2025→Jun 1, 2026 (now actual)
    + 3 other changes: index terms, verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06887426
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Oct 17, 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Oct 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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