Clinical trial NCT06675955: An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Official title: An Open-Label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-Trial Access Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Ocrelizumab
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-11-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\] 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 participants of childbearing potential.

Exclusion Criteria:

* 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 premature 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline up to 5 years
measure: Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 5 years
measure: Number of Participants with Adverse Events (AEs) Leading to Discontinuation
timeFrame: Up to 5 years
measure: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Amiens Cedex1
country: France
facility: CHU Amiens Hopital Sud
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Bron
country: France
facility: Hopital neurologique Pierre Wertheimer - CHU Lyon
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
city: Nice
country: France
facility: Hôpital Pasteur
city: Nimes
country: France
facility: GroupeHospitalo-Universitaire Caremeau
city: Ulm
country: Germany
facility: NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
city: Dnipro
country: Ukraine
facility: SI USSRI of Medical and Social Problems of Disabilities of MOHU
city: Kyiv
country: Ukraine
facility: Medical Center Dopomoga Plus
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: