Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)
Launched by RENNES UNIVERSITY HOSPITAL · Aug 28, 2018
Trial Information
Current as of July 05, 2025
Recruiting
Keywords
ClinConnect Summary
The STOP-I-SEP trial is studying whether stopping certain medications for Multiple Sclerosis (MS) can have a positive effect on patients who have been stable and not experiencing new symptoms for a while. Specifically, it looks at patients over 50 years old with a type of MS called secondary progressive MS, who have been on disease-modifying therapies for at least three years without any signs of active disease. The researchers want to determine if stopping these treatments will not worsen their disability and might even improve their quality of life while reducing costs associated with ongoing treatment.
To be eligible for this study, participants must be over 50 years old, have had a steady decline in their condition for at least three years, and have not shown any signs of active disease or relapses during that time. They should also have been on specific MS medications for at least three years. If you join the trial, you will be monitored closely to see how stopping treatment affects your health and quality of life. It’s important to note that this study aims to provide better guidelines for doctors in treating patients with MS in the future.
Gender
ALL
Eligibility 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, ...).
About Rennes University Hospital
Rennes University Hospital, a leading academic medical center in France, is dedicated to advancing healthcare through innovative clinical research and trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific research with clinical practice, fostering collaboration among multidisciplinary teams. Its commitment to excellence is reflected in its robust infrastructure and expertise in various medical fields, enabling the development and evaluation of novel therapies and treatment protocols. By participating in clinical trials, Rennes University Hospital aims to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montpellier, , France
Nancy, , France
Nîmes, , France
Tours, , France
Créteil, , France
Angers, , France
Poitiers, , France
Rennes, , France
Grenoble, , France
Strasbourg, , France
Nantes, , France
Lille, , France
Brest, , France
Bordeaux, , France
Dijon, , France
Nice, , France
Libourne, , France
Clermont Ferrand, , France
Lille, , France
Marseille, , France
Chartres, , France
Poissy, , France
Quimper, , France
Lyon, , France
Paris, , France
Paris, , France
Suresnes, , France
Patients applied
Trial Officials
Anne KERBRAT, Dr
Principal Investigator
CHU Rennes - National Headache Center
Clarisse SCHERER-GAGOU, Dr
Principal Investigator
University Hospital, Angers
Jean PELLETIER, Pr
Principal Investigator
AP-HM
Céline LOUAPRE, Dr
Principal Investigator
AP-HP La pitié Salpêtrière
Aurore JOURDAIN, Dr
Principal Investigator
CHU Brest
Pierre CLAVELOU, Pr
Principal Investigator
University Hospital, Clermont-Ferrand
Thibault MOREAU, Pr
Principal Investigator
CHU Dijon
Olivier CASEZ, Dr
Principal Investigator
University Hospital, Grenoble
Hélène ZEPHIR, Pr
Principal Investigator
CHU Lille
Sandra VUKUSIC, Pr
Principal Investigator
Hospices Civils de Lyon
Pierre LABAUGE, Pr
Principal Investigator
University Hospital, Montpellier
Guillaume MATHEY, Dr
Principal Investigator
CHU NANCY
David LAPLAUD, Pr
Principal Investigator
Nantes University Hospital
Christine LEBRUN-FRENAY, Pr
Principal Investigator
CHU NICE
Olivier HEINZLEF, Dr
Principal Investigator
CH Poissy
Jean-Philippe NEAU, Pr
Principal Investigator
CHU Poitiers
Marc COUSTANS, Dr
Principal Investigator
CH Quimper
Jérôme DE SEZE, Pr
Principal Investigator
CHU Strasbourg
Anne-Marie GUENNOC, Dr
Principal Investigator
CHU Tours
Caroline BENSA-KOSCHER, Dr
Principal Investigator
Fondation de Rothschild
Eric THOUVENOT, Pr
Principal Investigator
Centre Hospitalier Universitaire de Nīmes
Alain CREANGE, Pr
Principal Investigator
CH Henri Mondor
Arnaud KWIATKOWSKI, Dr
Principal Investigator
Hôpital Saint Vincent de Paul
Aurelie RUET, Pr
Principal Investigator
University Hospital, Bordeaux
Jérôme GRIMAUD, Dr
Principal Investigator
CH de Chartres
Maia TCHIKVILADZE, Dr
Principal Investigator
CH Foch
Philippe CASENAVE, Dr
Principal Investigator
CH de Libourne
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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