Ireland
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Active, not recruiting Phase 3

Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)

NCT03653273 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2019-01-24
Last updated
2026-03-30

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

DMT withdrawalDMT continuation

DMT withdrawal: Group 1 (DMT withdrawal) will not undergo any disease modifying treatments (DMT).

DMT continuation: Group 2 (DMT continuation) may undergo the DMT . The therapy continued in this research is the one previously established, at the same dose, not implying additional precautions for use.

Study summary

Further controlled and randomized prospective studies in Multiple sclerosis, analyzing the potential impact of treatment discontinuation on disability progression, focal disease activity and quality of life are needed. The optimum patient age and duration of inactive SPMS before treatment withdrawal and the monitoring procedures also need to be specified, the ultimate goal being to provide evidence-based recommendations for clinical practice. Following the previous retrospective experience, we decided to drive a multicenter prospective study in France based on the hypothesis that stopping disease modifying therapy will not induce an increased risk of disability progression and relapse in selected SPMS patients (older patients without lesion activity) but will improve the quality of life and may reduce treatment-related costs.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients \> 50 years old; * Secondary progressive phenotype for at least 3 years; The secondary progressive phenotype will be defined as progressive deterioration of disability not due to relapse, with an increase of at least 1 EDSS point since the beginning of the progressive phase (or 0.5 EDSS point if EDSS score ≥ 5.5). * Disease modifying therapy of MS for at least 3 years (interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, rituximab, ocrelizumab); Both patients with the same DMT or with successive DMTs during 3 years can be included. It is important to note that patients could have been treated with fingolimod or natalizumab 2 or 3 years before inclusion, but not during the year before inclusion ; * No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan); * EDSS≥3. Concomitant medications with Fampridine are allowed throughout the study, provided they have been introduced at least 1 months before inclusion. Natalizumab and fingolimod during the year before inclusion were excluded because of the risk of recurrence of inflammatory activity or even rebound of inflammatory activity after withdrawal. Both patients with the same DMT or with successive DMTs during 3 years can be included, as for example, cyclophosphamide is used for 1 or 2 years, sometimes followed by mycophenolate mofetil. For Rituximab and Ocrelizumab, inclusion in STOP-I-SEP will be at 6 months from the last infusion to take into account the mode of action of these treatments and their specific administration scheme. Exclusion Criteria: * Patients treated with mitoxantrone or alemtuzumab, during the previous 3 years before inclusion; * Patients treated with natalizumab or fingolimod during the year before inclusion; * Change of disease modifying therapy of MS for less than a year * Other neurological or systemic disease ; * Incapacity to understand or sign the consent form ; * Contraindication to MRI ; * Pregnancy or breast-feeding ; * Patient in another clinical trial * Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (eg minors, protected adults, …).

Primary outcome measure(s)

  • Disability progression measured by EDSS — 24 months
    Disability progression measured by the Percentage of patients experiencing disability progression (confirmed at 6 months) at 2 years. Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was more than 5.5.

Trial sites (27)

FacilityCityRegionStatus
CHU Angers Angers France
CHU de Bordeaux Bordeaux France
CHU Brest Brest France
CH de Chartres Chartres France
CHU Clermont-Ferrand Clermont-Ferrand France
Hôpital Henri Mondor Créteil France
CHU Dijon Dijon France
CHU Grenoble Grenoble France
CH de Libourne Libourne France
CHU Lille Lille France
Hôpital Saint Vincent de Paul Lille France
Hospices Civils Lyon Lyon France
AP-HM Marseille France
CHU Montpellier Montpellier France
CHU Nancy Nancy France
CHU Nantes Nantes France
CHU Nice Nice France
CHU de Nîmes Nîmes France
AP-HP (La Pitié Salpêtrière) Paris France
Fondation de Rothschild Paris France
CH Poissy Poissy France
CHU Poitiers Poitiers France
CH Quimper Quimper France
CHU Rennes Rennes France
CHU Strasbourg Strasbourg France
CH de Foch Suresnes France
CHU Tours Tours France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03653273 on ClinicalTrials.gov ↗ ← All trials in France