Primary Progressive Multiple SclerosisORATORIO-CortNCT05974839
Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)
An observational study of Primary Progressive Multiple Sclerosis, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Progressive Multiple Sclerosis
- What is being tested?
- Ocrelizumab
- How many people
- 732 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Primary Progressive Multiple Sclerosis
Who may be able to join
- Patient participating in the ORATORIO study
- MRI scans available at baseline
- Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 2D/3D T1-WI at baseline
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo Neuroimaging Analysis Center
Buffalo, New York, 14203
About this study
Official title: Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With Primary-progressive Multiple Sclerosis Participating in the ORATORIO: a Post-hoc Analysis of a Double-blind, Randomized, Phase 3, Placebo-controlled Study
The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.
Read the detailed description
To study the effect of ocrelizumab on cortical lesion accumulation in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study.
- Conditions
- Primary Progressive Multiple Sclerosis
- Being tested
- Ocrelizumab
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabOther
Non-interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical lesion number accumulation
Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.
Measured: 5 years
Secondary outcomes (1)
Cortical lesion number accumulation and disability.
Cortical lesion number accumulation as measured by MRI for subjects who developed disability over the course of the placebo-controlled phase of the study.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Oct 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974839
- Sponsor's protocol ID
- 00007536
- Acronym
- ORATORIO-Cort
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With Primary-progressive Multiple Sclerosis Participating in the ORATORIO: a Post-hoc Analysis of a Double-blind, Randomized, Phase 3, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05974839
- Acronym / sponsor ID
- ORATORIO-Cort / 00007536
- Conditions
- Primary Progressive Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.
Detailed description
To study the effect of ocrelizumab on cortical lesion accumulation in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Primary Progressive Multiple Sclerosis
Key inclusion criteria (3 listed)
- Patient participating in the ORATORIO study
- MRI scans available at baseline
- Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 2D/3D T1-WI at baseline
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabNon-interventional | Other | – |
Primary outcome
Cortical lesion number accumulation
Time frame: 5 years
Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.
1 secondary outcome
Cortical lesion number accumulation and disability.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Progressive Multiple Sclerosis, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical lesion number accumulation (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.