progressive multiple sclerosis MedDRA version: 21.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: OCREVUS
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
University Nice Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent form (ICF) • Able to comply with the study protocol, in the investigator’s judgment • Affiliation to the social security system • Completed the treatment period of Roche-sponsored ocrelizumab trial (CONSONANCE) and who in the opinion of the investigator may benefit from treatment with ocrelizumab. Only patients enrolled under Protocol version 1 (approval date: 18 February 2018) will be eligible. • Meet re-treatment criteria with ocrelizumab (please see section 6.11) • Patients who became pregnant by chance between the last visit of the CONSONANCE study and screening of this study, as confirmed by pregnancy tests at screening, will enter the study but will only re-start treatment with ocrelizumab after birth or after breastfeeding is stopped, as per re-treatment criteria in section 6.11 • Women of childbearing potential* (WOCBP): o Must have a negative urine pregnancy test at Visit 1 (Screening) and Visit 2 (Baseline) o Must agree to remain abstinent or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet 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 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: • Hypersensitivity to ocrelizumab or any of its excipients • Patients in a severely immunocompromised state, until the condition resolves • Evidence of any AE potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation • Existence of a contra-indication as per the SmPC • Prohibited concomitant medication as specified in section 6.7 • Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug in CONSONANCE • Patients who had early ocrelizumab discontinuation in CONSONANCE (exemption made for treatment discontinuation due to unplanned pregnancy and breastfeeding for patients who continued clinical study assessments in CONSONANCE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effectiveness of ocrelizumab on upper extremity disability progression. ;Secondary Objective: The secondary objective of this study is to evaluate the long-term effectiveness of ocrelizumab (including preventing or delaying the time to significant disability outcomes) in patients with progressive MS who have completed CONSONANCE.;Primary end point(s): The primary objective will be measured on upper limbs, based the following endpoint: proportion of patients with upper limb disability progression, defined as the proportion of patients with =20% worsening in 9-HPT score confirmed for at least 24 weeks, from baseline to Week 192.;Timepoint(s) of evaluation of this end point: from baseline to Week 192. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives will be measured: The proportion of patients reaching confirmed EDSS =7.0 (i.e., requiring the use of a wheelchair) between baseline and Week 192, for patients with a baseline EDSS <7.0 • The proportion of patients reaching confirmed EDSS =6.0 (i.e., requiring a walking aid to walk about 100 m with or without resting) between baseline and Week 192, for patients with a baseline EDSS <6.0 • The proportion of patients with 24-week CDP in EDSS, defined as an increase in EDSS score that is confirmed for at least 24 weeks (an increase of ?1.0 point from baseline EDSS in patients with a baseline EDSS score ? 5.5 or an increase of ? 0.5 point in patients with a baseline EDSS score of ?5.5) • The proportion of patients with =20% worsening in 25FWT score confirmed for at least 24 weeks, from baseline to Week 192, in patients who are ambulatory at baseline • The proportion of relapse*-free patients by Week 192 • The proportion of patients with T1 gadolinium-enhancing lesions as detected by brain magnetic resonance imaging (MRI) at Weeks 48, 96, 144 and 192 • The proportion of patients with new, and/or enlarging T2 hyperintense lesions as detected by brain MRI at Weeks 48, 96, 144 and 192 • The proportion of patients with NEP defined as no progression sustained for at least 24 weeks on all of the following three components (EDSS; =20% increase in 25FWT; =20% increase in 9-HPT) from baseline to Week 192 • The proportion of patients with NEPAD defined as no progression sustained for at least 24 weeks on all of the three components of NEP (EDSS, 25FWT, 9-HPT), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium-enhancing lesion from baseline to Week 192 ;Timepoint(s) of evaluation of this end point: from baseline to Week 192. | — |
Countries
France
Contacts
Public Contactreseach project manager
University Nice Hospital
Outcome results
None listed