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STOP-I-SEP_Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years
EU CTIS ID: 2024-516628-32-00
What this study is testing
To demonstrate the non-inferiority of DMTs withdrawal compared to treatment continuation at 2 years, on disability progression, in “inactive” SPMS patients older than 50 years. The definition of “inactive” SPMS patients refers to the Lublin classification : SPMS patients without recent evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no radiological activity)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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)
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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, …)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.