Cladribine Tablets as an Exit Therapy Strategy

Not yet recruiting

• Conditions: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
• Interventions: Drug: Cladribine

• Registration Number: NCT06887426
• Lead Sponsor: University Hospital, Strasbourg, France

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.

We 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2025-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cladribine group	Cladribine	-

Primary Outcome Measures

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

Name	Time	Method
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and stopping current DMT	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
To evaluate the clinical activity during the 3 years of follow-up in patients switching to cladribine and continuing current DMT	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
To evaluate the radiological activity during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT	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
To evaluate the disability during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT	2 years	Proportion 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 DMT	2 years	Proportion of patients with any serious adverse events after 2 years in patients switching to cladribine and continuing current DMT

Trial Locations

Locations (1)

Service de neurologie - Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France