Secondary Progressive Multiple Sclerosis MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: AVONEX
Pharmaceutical Form: Concentrate for solution for injection
Product Name: BETAFERON
Product Code: L03 AB 08
Pharmaceutical Form: Powder for solution for injection
Product Name:
Sponsors
CHU de Rennes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients > or = 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, fingolimod, natalizumab, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil); Both patients with the same DMT or with successive DMTs during 3 years can be included; - No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan) ; - EDSS = 3. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 225 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - Patients treated with mitoxantrone, alentuzumab, rituximab or ocrelizumab during the previous 3 years 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, …).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 relapase and no radiological activity) ;Secondary Objective: To compare the 2 groups at 2 years (treatment withdrawal vs treatment continuation) for: - Disability progression using a composite score; - Relapses; - MRI parameters; - Disease-free survival; - Patients quality of life; - Medico-economic impact: cost-utility study (differential cost per QALY gained). ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 24 months' follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disability 1 _Time from DMT withdrawal to disability progression confirmed at 6 months; 2_ 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; 3_Change in the SDMT score from baseline to 2-year; Relapses 4_Percentage of patients with at least one relapse from baseline to 2-year; 5_Annualized relapse rate during 2-year; 6_Time from DMT withdrawal to first relapse; Relapses will be defined as new or worsening neurologic symptoms related to MS, not associated with fever or infection, lasting at least 48 hours, with an objective change on neurological examination assessed by a masked rater at an unscheduled visit corresponding to the reported symptoms. An objective change is defined as one point on two functional system scales or two points on one functional system scale or increase in the EDSS score. An MRI scan will be systematically performed within 2 months after a suspected relapse. MRI 7_Percentage of patients with one or more new or enlarging brain MRI lesions from baseline to 2-year; 8_Percentage of patients with at least one gadolinium enhancing lesion(s) at 6 months and/or 1-year and/or 2-year; 9_Percentage of change in brain volume from baseline to 2-year; Disease free survival 10_Percentage of patients with no evidence of disease activity (NEDA 3: no clinical relapse, no MRI activity, no disability progression) at 2-year; 11_Percentage of patients who resume first-line treatment in the treatment withdrawal group at 2-year; Quality of life 12_Change in the SEP-59 score from baseline to 2-year; Medico economic impact 13_Incremental Cost Effectiveness Ratio (ICER) defined as the cost for QALY gained in “treatment withdrawal group” versus “treatment continued group”. ;Timepoint(s) of evaluation of this end point: 1 / 24 months' f | — |
Countries
France
Contacts
Public ContactLEROYER Isabelle
CHU de Rennes
Outcome results
None listed