No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
This trial is looking for people with Multiple Sclerosis who have been on ocrelizumab treatment in previous studies. Participants will continue receiving the medication and share their experiences with its impact on physical function.
Are You a Good Fit for This Trial?
You may be able to join if
I have been on ocrelizumab treatment in a previous study
I have not had access to ocrelizumab locally
I will receive my first dose in this trial at least 5 months after my last dose in the previous study
I am a woman of childbearing potential and will have a negative pregnancy test before starting
You may not be able to join if
I have access to ocrelizumab through my country’s market
I can get ocrelizumab through a Post Trial Access Program
I stopped my previous study treatment permanently for any reason
I have a condition that could interfere with my safety during the trial
I am participating in another clinical trial
I have an immunocompromised state
I have an active cancer or am being monitored for cancer
I have other neurological disorders
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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), MN439…
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
Contacts
Reference Study ID Number: MN45053 https://forpatients.roche.com/
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
