TERIFLUNOMIDE for Multiple Sclerosis

Inclusion criteria

• {"criterion_text":"- 1.\tPatient (male or female) aged 55 and over\n- 2.\tRRMS (Relapsing-Remitting Multiple Sclerosis) diagnosis according to revised McDonald 2017 criteria\n- 3.\tFirst MS symptom > 5 years ago. If the date is unknown, RRMS diagnosis > 5 years ago\n- 4.\tStable disease in the last 5 years according to the revised Lublin and Reingold classification 19 characterized by : a)\tStable 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)\tNon-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)\tThe absence of relapses within 5 years prior to the inclusion visit\n- 5.\tTreated 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."}

Exclusion criteria

• {"criterion_text":"- 1.\tPrimary progressive or secondary progressive with or without relapse as defined by the revised Lublin and Reingold classification\n- 2.\tPrevious 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\n- 3.\tContraindication 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\n- 4.\tHistory 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…\n- 5.\tChronic disease which requires chronic treatment with corticoids or immunosuppressors\n- 6.\tUncontrolled cardiac, renal or hepatic disease"}

Primary endpoints

• {"endpoint_text":"- Time to first clinical and/or radiological disease activity during a period of 2 years.","definition_or_measurement_approach":"Defined as time to first clinical and/or radiological disease activity over a 2-year period, assessed by clinical evaluation and radiological (MRI) evidence."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints will be measured by comparing baseline scores/evaluations (M0) with the scores/evaluations at M6, M12, M18, and M24: 1.\tKaplan Meier analysis of time to relapse","definition_or_measurement_approach":"Measured by comparing baseline (M0) to M6/M12/M18/M24; Kaplan-Meier analysis of time to relapse."}
• {"endpoint_text":"- 2.\tAnnual relapse rate (ARR)","definition_or_measurement_approach":"Annualised relapse rate calculated over follow-up visits (M6, M12, M18, M24) compared to baseline."}
• {"endpoint_text":"- 3.\tTransition to secondary progressive multiple sclerosis according to revised McDonald 2017 criteria","definition_or_measurement_approach":"Assessed according to revised McDonald 2017 criteria during scheduled follow-up visits."}
• {"endpoint_text":"- 4.\tScores at EDSS, 25Foot/Walk, 9-HPT tests","definition_or_measurement_approach":"Disability and function measured using EDSS, 25-Foot Walk, and 9-Hole Peg Test at baseline and scheduled visits (M6, M12, M18, M24)."}
• {"endpoint_text":"- 5.\tScores at CSCT questionnaire","definition_or_measurement_approach":"Cognitive function assessed with CSCT (Computerized Speed Cognitive Test) at scheduled visits."}
• {"endpoint_text":"- 6.\tScores at SEP-59, EQ-5D, Hospital Anxiety and Depression (HAD) and Burden of Treatment (TBQ) Questionnaires","definition_or_measurement_approach":"Patient-reported outcomes and quality-of-life measured using SEP-59, EQ-5D, HADS, and TBQ questionnaires at scheduled visits."}
• {"endpoint_text":"- 7.\tSafety of treatments will be followed by the number and type of adverse or severe adverse events (AE/SAE) throughout the protocol ; Clinical examination, patient questioning; biological analysis in the case of suspected infection","definition_or_measurement_approach":"Safety monitored by recording number and type of AEs/SAEs throughout protocol via clinical exam, patient interview, and biological analyses (e.g., NFS, platelets, CRP, ASAT/ALAT, urine dipstick) when infection suspected."}
• {"endpoint_text":"- 8.\tMS comorbidities questionnaire","definition_or_measurement_approach":"Assessed via self-reported MS comorbidities questionnaire at visits."}
• {"endpoint_text":"- 9.\tAverage annual cost, incremental ratio cost/effectiveness and cost/utility ratios","definition_or_measurement_approach":"Health economic outcomes including average annual cost, incremental cost-effectiveness and cost-utility ratios calculated from collected resource use and outcomes."}

France

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

574

Number Of Sites

22

Number Of Participants

200

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France