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DISEASE MODIFYING THERAPIES WITHDRAWAL IN INACTIVE RELAPSING-REMITTING MULTIPLE SCLEROSIS PATIENTS AGED 55 AND OVER: A MULTICENTRIC, RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL - TWINS
EU CTIS ID: 2024-513475-41-00
What this study is testing
To demonstrate the non-inferiority in disease activity-free survival between continuation and discontinuation of treatment in stable RRMS patients aged 55 and over. These results could lead to a modification of the standard care protocol to meet the needs of older populations.
- 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
- 1. Patient (male or female) aged 55 and over
- 2. RRMS (Relapsing-Remitting Multiple Sclerosis) diagnosis according to revised McDonald 2017 criteria
- 3. First MS symptom > 5 years ago. If the date is unknown, RRMS diagnosis > 5 years ago
- 4. Stable disease in the last 5 years according to the revised Lublin and Reingold classification 19 characterized by : a) Stable T2 lesions related to MS documented by brain MRI performed at least 5 years prior to inclusion versus MRI performed within 6 months prior to the inclusion visit, AND b) Non-worsened EDSS documented at least 5 years prior to inclusion versus EDSS documented within 6 months prior to inclusion visit, according to the investigator's judgment, AND c) The absence of relapses within 5 years prior to the inclusion visit
- 5. Treated with a Moderate Efficacy Therapy (MET) for at least 5 consecutive years (IFN-β, glatiramer acetate, dimethyl fumarate, teriflunomide, diroximel fumarate) strictly used in accordance with their marketing authorization; switching from one first-line treatment to another is accepted if the reason for the change is related to personal convenience or intolerance to the first treatment.
You likely can't join if
- 1. Primary progressive or secondary progressive with or without relapse as defined by the revised Lublin and Reingold classification
- 2. Previous or ongoing treatment with a High Efficacy therapy (HET), with the exception of induction therapy (mitoxantrone, stem cell transplantation, alemtuzumab) provided that the last administration took place at least 10 years prior to inclusion
- 3. Contraindication to MRI (claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, foreign body in eye, intracranial vascular clips, surgery in the 6 weeks prior to the beginning of the study, coronary stent implanted in the 8 weeks prior to the beginning of the study,…). NB: Gadolinium contraindication will not prevent recruitment of the patient; in this case MRI will be carried out without contrast product injection
- 4. History of neurological disease affecting the central nervous system: hereditary degenerative CNS disease, degenerative cognitive disease, clinical or radiological history of a clinically significant cerebral arteriovenous malformation, or one that has bled, systemic autoimmune disease, sarcoidosis, Lyme disease…
- 5. Chronic disease which requires chronic treatment with corticoids or immunosuppressors
- 6. Uncontrolled cardiac, renal or hepatic disease
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.