Relapsing multiple sclerosis (RMS)
Conditions
Brief summary
Proportion of subjects with adverse events, Proportion of subjects with laboratory, or vital signs results meeting abnormal criteria, Proportion of subjects with electrocardiogram (ECG) meeting abnormal criteria [through Week 240 (EOS)], Proportion of subjects meeting predefined criteria in Columbia Suicide Severity Rating Scale (C SSRS) [through Week 240/EOS]
Detailed description
Through Week 240/EOS: • Annualized Relapse Rate (ARR), Through Week 240/EOS: • Time to first relapse, Through Week 240/EOS: • Time to 3-month Confirmed Disability Worsening (3mCDW), Through Week 240/EOS: • Time to 6-month Confirmed Disability Worsening (6mCDW), Through Week 240/EOS: • Time to 6-month Confirmed Disability Improvement (6mCDI), Through Week 240/EOS: • Time to 12-month Confirmed Disability Improvement (12mCDI), Through Week 240/EOS: • Time to 24-month Confirmed Disability Improvement (24mCDI), Through Week 240/EOS: • Time to 6-month Confirmed Disability Improvement (6mCDI) sustained until End of Study (EOS), Through Week 240/EOS: • Change in Expanded Disability Status Scale (EDSS), Through Week 240/EOS: • Time to 6-month confirmed 4-point worsening on Symbol Digit Modalities Test (SDMT), Through Week 240/EOS: • Change in SDMT, Through Week 240/EOS: • Annualized T2 lesion rate, Through Week 240/EOS: • Number of T1 Gd-enhancing lesions per Magnetic Resonance Image (MRI) scan, Through Week 240/EOS: • Annual rate of change in brain volume, Through Week 240/EOS: • Change in neurofilament light chain (NfL) concentration in serum, Through Week 240/EOS: • Relationship between NFL and disease activity, disease course and treatment response, Through Week 240/EOS: • Patient Reported Outcomes (PRO)
Interventions
DRUGBOOSTRIX
DRUGsuspension injectable en seringue préremplie Vaccin diphtérique
DRUGtétanique et coquelucheux (acellulaire multicomposé)
DRUG(adsorbé
DRUGà teneur réduite en antigènes)
DRUGPneumovax 23 oldatos injekció Pneumococcus-poliszacharid vakcina
DRUGPNEUMOVAX solution injectable en flacon Vaccin pneumococcique polyosidique
DRUGBoostrix suspensión inyectable en jeringa precargada Vacuna antidiftérica
DRUGantitetánica y antitos ferina (componente acelular) (adsorbida
DRUGcontenido antigénico reducido)
DRUGPneumovax 23 oldatos injekció előretöltött fecskendőben Pneumococcus-poliszacharid vakcina
DRUGPNEUMOVAX 23 Injektionslösung in einer Durchstechflasche Pneumokokken-Polysaccharid-Impfstoff
DRUGBoostrix* Diphtherie-Tetanus-Pertussis (azellular)-Kombinationsimpfstoff zur Auffrischimpfung
DRUGBoostrix
DRUGsuspenzija za injekciju u napunjenoj štrcaljki
DRUGcjepivo protiv difterije
DRUGtetanusa i pertusisa (nestanicno
DRUGkomponentno)
DRUGadsorbirano
DRUGsmanjenog(ih) sadržaja antigena
DRUGFlucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen
DRUGinactivated
DRUGFlucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen
DRUGPNEUMOVAX 23 Szczepionka przeciw pneumokokom
DRUGpolisacharydowa
DRUGBoostrix zawiesina do wstrzykiwań w ampułko-strzykawce|Szczepionka przeciw błonicy
DRUGtężcowi i krztuścowi (bezkomórkowa
DRUGzłożona)
DRUGadsorbowana
DRUGo|zmniejszonej zawartości antygenów
DRUGBoostrix szuszpenziós injekció előretöltött fecskendőben diphtheria
DRUGtetanus és pertussis (acelluláris összetevő) vakcina (adszorbeált
DRUGcsökkentett antigén tartalmú)
DRUGPneumovax 23 otopina za injekciju u napunjenoj štrcaljki Cjepivo protiv pneumokoka
DRUGpolisaharidno
DRUGBoostrix szuszpenziós injekció eloretöltött fecskendoben diphtheria
DRUGtetanus és pertussis (acelluláris összetevo) vakcina (adszorbeált
DRUGadsorbed)
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with adverse events, Proportion of subjects with laboratory, or vital signs results meeting abnormal criteria, Proportion of subjects with electrocardiogram (ECG) meeting abnormal criteria [through Week 240 (EOS)], Proportion of subjects meeting predefined criteria in Columbia Suicide Severity Rating Scale (C SSRS) [through Week 240/EOS] | — |
Secondary
| Measure | Time frame |
|---|---|
| Through Week 240/EOS: • Annualized Relapse Rate (ARR), Through Week 240/EOS: • Time to first relapse, Through Week 240/EOS: • Time to 3-month Confirmed Disability Worsening (3mCDW), Through Week 240/EOS: • Time to 6-month Confirmed Disability Worsening (6mCDW), Through Week 240/EOS: • Time to 6-month Confirmed Disability Improvement (6mCDI), Through Week 240/EOS: • Time to 12-month Confirmed Disability Improvement (12mCDI), Through Week 240/EOS: • Time to 24-month Confirmed Disability Improvement (24mCDI), Through Week 240/EOS: • Time to 6-month Confirmed Disability Improvement (6mCDI) sustained until End of Study (EOS), Through Week 240/EOS: • Change in Expanded Disability Status Scale (EDSS), Through Week 240/EOS: • Time to 6-month confirmed 4-point worsening on Symbol Digit Modalities Test (SDMT), Through Week 240/EOS: • Change in SDMT, Through Week 240/EOS: • Annualized T2 lesion rate, Through Week 240/EOS: • Number of T1 Gd-enhancing lesions per Magnetic Resonance Image (MRI) scan | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden
Outcome results
None listed