An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
- Registration Number
- NCT06675955
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies [Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)] at the time of roll-over and who do not have access to the ocrelizumab treatment locally.
- The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study.
- Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential.
- Study treatment is commercially marketed in the participant's country for the participant specific disease and is reasonably accessible to the participant.
- Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant.
- Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable).
- Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications.
- Concurrent participation in any therapeutic clinical trial (other than the parent study).
- Immunocompromised state
- Known active malignancy or are being actively monitored for recurrence of malignancy.
- Known presence of other neurological disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ocrelizumab Ocrelizumab Participants will receive ocrelizumab at the same dose and schedule as the parent study until access to the treatment becomes locally available, unacceptable safety concern, death or withdrawal of consent.
- Primary Outcome Measures
Name Time Method Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders-Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a) Baseline up to 5 years PROMISnq PFMS-15a includes 15 items that evaluate the impact of MS on a participant's physical functioning, including mobility, upper limb function and activities of daily living. Nine items assess the degree of difficulty in completing physical activities using a 5 point verbal rating scale ranging from 5="without any difficulty" to 1="unable to do". Four items assess physical function limitations, rated from 5="not at all" to 1="cannot do". Two items assess the amount of difficulty associated with selected physical activities, rated from 5="no difficulty" to 1="can't do". Scores are reported as a standardized T-score metric, with higher scores reflecting better physical functioning.
Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study Up to 5 years
- Secondary Outcome Measures
Name Time Method Number of Participants with Serious Adverse Events (SAEs) Up to 5 years Number of Participants with Adverse Events (AEs) Leading to Discontinuation Up to 5 years Number of Participants with Adverse Events of Special Interest (AESIs) Up to 5 years
Trial Locations
- Locations (11)
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
🇩🇪Westerstede, Germany
Deutsche Klinik für Diagnostik
🇩🇪Wiesbaden, Germany
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Hopital neurologique Pierre Wertheimer - CHU Lyon
🇫🇷Bron, France
Hopital Gabriel Montpied CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Hopital Gui de Chauliac
🇫🇷Montpellier, France
Hôpital Pasteur
🇫🇷Nice, France
GroupeHospitalo-Universitaire Caremeau
🇫🇷Nimes, France
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
🇩🇪Ulm, Germany
SI USSRI of Medical and Social Problems of Disabilities of MOHU
🇺🇦Dnipro, Ukraine
Medical Center Dopomoga Plus
🇺🇦Kyiv, Ukraine