INTERFERON BETA-1B for Secondary progressive multiple sclerosis | Multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Patients ≥ 50 years old"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan)"}
• {"criterion_text":"- EDSS ≥ 3"}

Exclusion criteria

• {"criterion_text":"- Patients treated with mitoxantrone or alemtuzumab, during the previous 3 years before inclusion"}
• {"criterion_text":"- Patients treated with natalizumab or fingolimod during the year before inclusion"}
• {"criterion_text":"- Change of disease modifying therapy of MS for less than a year"}
• {"criterion_text":"- Other neurological or systemic disease"}
• {"criterion_text":"- Incapacity to understand or sign the consent form"}
• {"criterion_text":"- Contraindication to MRI"}
• {"criterion_text":"- Pregnancy or breast-feeding"}
• {"criterion_text":"- Patient in another clinical trial"}
• {"criterion_text":"- 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, …)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Disability progression confirmed at 6 months at 2 years; defined as increase in EDSS of ≥1 point if baseline EDSS ≤5.5, or ≥0.5 point if baseline EDSS >5.5. Measurement: EDSS assessments with confirmation at 6 months."}

Secondary endpoints

• {"endpoint_text":"- Disability - Time from DMT withdrawal to disability progression confirmed at 6 months; - Change in a composite disability progression score (increase in the EDSS score, or an increase in the time to perform the timed 25-foot walk ≥ 20%, or an increase in the time to complete the 9-hole peg test ≥ 20%) confirmed at 6 months; - Change in the SDMT score from baseline to 2-year;","definition_or_measurement_approach":"Measures include time-to-event (time from withdrawal to disability progression confirmed at 6 months), composite disability progression combining EDSS, timed 25-foot walk (≥20% change), 9-hole peg test (≥20% change) with 6-month confirmation; SDMT change from baseline to 2 years."}
• {"endpoint_text":"- Relapses - Percentage of patients with at least one relapse from baseline to 2-year; - Annualized relapse rate during 2-year; - Time from DMT withdrawal to first relapse;","definition_or_measurement_approach":"Relapse endpoints: proportion with ≥1 relapse over 2 years; annualized relapse rate over 2 years; time-to-first relapse after DMT withdrawal."}
• {"endpoint_text":"- MRI -\t Percentage of patients with one or more new or enlarging brain MRI lesions from baseline to 2-year; -\t Percentage of patients with at least one gadolinium enhancing lesion(s) at 6 months, and/or 1 year,and/or 2-year; -\t Change in brain volume from baseline to 2-year;","definition_or_measurement_approach":"MRI endpoints: presence of new/enlarging T2 lesions from baseline to 2 years; proportion with gadolinium-enhancing lesion(s) at 6 months/1 year/2 years; percent brain volume change from baseline to 2 years."}
• {"endpoint_text":"- Disease free survival -\t Percentage of patients with no evidence of disease activity (NEDA 3: no clinical relapse, no MRI activity, no disability progression) at 2-year; -\t Percentage of patients who resume DMT in the treatment withdrawal group at 2-year","definition_or_measurement_approach":"NEDA-3 at 2 years (no clinical relapse, no MRI activity, no disability progression). Also proportion of patients in withdrawal arm who resume DMT by 2 years."}
• {"endpoint_text":"- Quality of life -\t Change in the SEP-59 score from baseline to 2-year; -\tChange in the EuroQOL EQ-5D from baseline to 2-year;","definition_or_measurement_approach":"QoL endpoints: change from baseline to 2 years in SEP-59 and EQ-5D questionnaires."}
• {"endpoint_text":"- Medico economic impact -\t Incremental Cost Effectiveness Ratio (ICER) defined as the cost for QALY gained in “treatment withdrawal group” versus “treatment continued group”.","definition_or_measurement_approach":"Health economic endpoint: ICER expressed as cost per QALY gained comparing withdrawal versus continuation over the study period."}

France

Earliest CTIS Part Ii Submission Date

27-09-2024

Latest Decision Or Authorization Date

10-04-2026

Processing Time Days

560

Number Of Sites

24

Number Of Participants

250

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Rennes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France