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

NCT03653273 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 35RC17_8842_STOP-I-SEP
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; secondary progressive; disease modifying treatment; medico economic impact; treatment withdrawal

Outcome Measures

Primary Outcomes (1)

• Disability progression measured by EDSS

  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.

  24 months

Secondary Outcomes (14)

• Time of Disability progression

  24 months

• Disability progression measured by composite score

  24 months

• Disability progression measured by SDMT

  24 months

• Percentage of patients with Relapse

  24 months

• Annualized relapse rate

  24 months

Study Arms (2)

DMT withdrawal

EXPERIMENTAL

DMT will be immediately stopped after randomization.These patients will be followed for 2 years.

Other: DMT withdrawal

DMT continuation

ACTIVE COMPARATOR

The previously established therapy will be continued at the same dose during two years.

Drug: DMT continuation

Interventions

DMT withdrawal OTHER

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

DMT withdrawal

DMT continuation DRUG

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.

DMT continuation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan);
• EDSS≥3.
• 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.

You may not qualify if:

• 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, …).

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (27)

CHU Angers

Angers, France

Location

CHU de Bordeaux

Bordeaux, France

Location

CHU Brest

Brest, France

Location

CH de Chartres

Chartres, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpital Henri Mondor

Créteil, France

Location

CHU Dijon

Dijon, France

Location

CHU Grenoble

Grenoble, France

Location

CH de Libourne

Libourne, France

Location

CHU Lille

Lille, France

Location

Hôpital Saint Vincent de Paul

Lille, France

Location

Hospices Civils Lyon

Lyon, France

Location

AP-HM

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

CHU de Nîmes

Nîmes, France

Location

AP-HP (La Pitié Salpêtrière)

Paris, France

Location

Fondation de Rothschild

Paris, France

Location

CH Poissy

Poissy, France

Location

CHU Poitiers

Poitiers, France

Location

CH Quimper

Quimper, France

Location

CHU Rennes

Rennes, France

Location

CHU Strasbourg

Strasbourg, France

Location

CH de Foch

Suresnes, France

Location

CHU Tours

Tours, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anne KERBRAT, Dr

  CHU Rennes - National Headache Center

  PRINCIPAL INVESTIGATOR

• Clarisse SCHERER-GAGOU, Dr

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Jean PELLETIER, Pr

  AP-HM

  PRINCIPAL INVESTIGATOR

• Céline LOUAPRE, Dr

  AP-HP La pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

• Aurore JOURDAIN, Dr

  CHU Brest

  PRINCIPAL INVESTIGATOR

• Pierre CLAVELOU, Pr

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• Thibault MOREAU, Pr

  CHU Dijon

  PRINCIPAL INVESTIGATOR

• Olivier CASEZ, Dr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Hélène ZEPHIR, Pr

  CHU Lille

  PRINCIPAL INVESTIGATOR

• Sandra VUKUSIC, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Pierre LABAUGE, Pr

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Guillaume MATHEY, Dr

  CHU NANCY

  PRINCIPAL INVESTIGATOR

• David LAPLAUD, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Christine LEBRUN-FRENAY, Pr

  CHU NICE

  PRINCIPAL INVESTIGATOR

• Olivier HEINZLEF, Dr

  CH Poissy

  PRINCIPAL INVESTIGATOR

• Jean-Philippe NEAU, Pr

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

• Marc COUSTANS, Dr

  CH Quimper

  PRINCIPAL INVESTIGATOR

• Jérôme DE SEZE, Pr

  CHU Strasbourg

  PRINCIPAL INVESTIGATOR

• Anne-Marie GUENNOC, Dr

  CHU Tours

  PRINCIPAL INVESTIGATOR

• Caroline BENSA-KOSCHER, Dr

  Fondation de Rothschild

  PRINCIPAL INVESTIGATOR

• Eric THOUVENOT, Pr

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Alain CREANGE, Pr

  CH HENRI MONDOR

  PRINCIPAL INVESTIGATOR

• Arnaud KWIATKOWSKI, Dr

  Hôpital Saint Vincent de Paul

  PRINCIPAL INVESTIGATOR

• Aurelie RUET, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Jérôme GRIMAUD, Dr

  CH de Chartres

  PRINCIPAL INVESTIGATOR

• Maia TCHIKVILADZE, Dr

  CH Foch

  PRINCIPAL INVESTIGATOR

• Philippe CASENAVE, Dr

  CH de Libourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: January 24, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (27)