Cladribine Tablets as an Exit Therapy Strategy

NCT06887426 | Not Yet Recruiting

• 1 other identifier: 9628
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Outcome Measures

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

  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

  2 years

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

  2 years

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

  2 years

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

  2 years

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

  2 years

Study Arms (2)

Cladribine group

Drug: Cladribine

Continuing treatment group

Interventions

Cladribine DRUG

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

Cladribine group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de neurologie - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 2, 2025

Record last verified: 2025-03

Locations

FR (1)