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Withdrawing treatment for older patients with inactive secondary progressive multiple sclerosis

Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years

PHASE3 · Rennes University Hospital · NCT03653273

This study is testing whether stopping treatment for older patients with inactive secondary progressive multiple sclerosis will affect their disability, quality of life, or treatment costs.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment250 (estimated)
Ages50 Years and up
SexAll
SponsorRennes University Hospital (other)
Drugs / interventionsrituximab, ocrelizumab, natalizumab, alemtuzumab, methotrexate, cyclophosphamide
Locations27 sites (Angers and 26 other locations)
Trial IDNCT03653273 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of discontinuing disease-modifying therapies (DMTs) in patients over 50 years old with inactive secondary progressive multiple sclerosis (SPMS). It aims to determine whether stopping treatment will lead to increased disability progression or relapse, while also assessing the impact on quality of life and treatment costs. The study will involve a multicenter approach in France, focusing on patients who have had no focal inflammatory activity for at least three years. The ultimate goal is to provide evidence-based recommendations for clinical practice regarding treatment withdrawal in this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients over 50 years old with inactive secondary progressive multiple sclerosis who have been on DMT for at least three years.

Not a fit: Patients with active disease or those who have not been on DMT for the required duration may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved quality of life and reduced treatment costs for older patients with inactive SPMS.

How similar studies have performed: While there have been studies on DMTs in MS, this specific approach to treatment withdrawal in older patients with inactive SPMS is relatively novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, ...).

Where this trial is running

Angers and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Multiple Sclerosis, multiple sclerosis, secondary progressive, disease modifying treatment, medico economic impact, treatment withdrawal

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.