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MS drug holiday for Over-50s: safe or risky?

NCT ID NCT03653273

Disease control Sponsor: Rennes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether people over 50 with a stable, inactive form of secondary progressive multiple sclerosis can stop taking their disease-modifying drugs without getting worse. Researchers will track 250 participants for 2 years to see if stopping treatment leads to more disability or relapses, and whether it improves quality of life and reduces costs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, …).

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Conditions

The condition(s) this trial relates to.

multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • AP-HM

    Marseille, France

  • AP-HP (La Pitié Salpêtrière)

    Paris, France

  • CH Poissy

    Poissy, France

  • CH Quimper

    Quimper, France

  • CH de Chartres

    Chartres, France

  • CH de Foch

    Suresnes, France

  • CH de Libourne

    Libourne, France

  • CHU Angers

    Angers, France

  • CHU Brest

    Brest, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU Dijon

    Dijon, France

  • CHU Grenoble

    Grenoble, France

  • CHU Lille

    Lille, France

  • CHU Montpellier

    Montpellier, France

  • CHU Nancy

    Nancy, France

  • CHU Nantes

    Nantes, France

  • CHU Nice

    Nice, France

  • CHU Poitiers

    Poitiers, France

  • CHU Rennes

    Rennes, France

  • CHU Strasbourg

    Strasbourg, France

  • CHU Tours

    Tours, France

  • CHU de Bordeaux

    Bordeaux, France

  • CHU de Nîmes

    Nîmes, France

  • Fondation de Rothschild

    Paris, France

  • Hospices Civils Lyon

    Lyon, France

  • Hôpital Henri Mondor

    Créteil, France

  • Hôpital Saint Vincent de Paul

    Lille, France

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