Multiple SclerosisCLADREXITNCT06887426
Cladribine Tablets as an Exit Therapy Strategy
An observational study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- What is being tested?
- Cladribine
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Progressive form of MS
- Patients without DMT
- EDSS score ≥6.5
Trial locations and contacts
1 site in 1 country.
France1 site
Service de neurologie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
About this study
Official title: Cladribine Tablets as an Exit Therapy Strategy: Alternative to Continuing Treatment and Plain Treatment Discontinuation in Ageing Stable RMS Patients
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.
Read more
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
- Being tested
- Cladribine
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CladribineDrug
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT
| Study group | Role | What they receive |
|---|---|---|
| Cladribine group | Not described Receives: Drug: Cladribine | |
| Continuing treatment group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (5)
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
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start17 Oct 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887426
- Sponsor's protocol ID
- 9628
- Acronym
- CLADREXIT
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cladribine Tablets as an Exit Therapy Strategy: Alternative to Continuing Treatment and Plain Treatment Discontinuation in Ageing Stable RMS Patients
- ClinicalTrials.gov ID
- NCT06887426
- Acronym / sponsor ID
- CLADREXIT / 9628
- Conditions
- Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cladribine group | – | Drug: Cladribine |
| Continuing treatment group | – | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Progressive form of MS
- Patients without DMT
- EDSS score ≥6.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CladribineTo evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT | Drug | Cladribine group |
Primary outcome
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
5 secondary outcomes
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
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
To evaluate the radiological activity during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT
Time frame: 2 years
To evaluate the disability during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT
Time frame: 2 years
To evaluate the risk of serious adverse events in patients switching to cladribine and continuing current DMT
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.