Effect of Ocrelizumab on Cortical Lesion Accumulation in... | NCT05974839

Studies
Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)

NCT05974839

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Sep 26, 2024Actual

Enrollment

732Actual

Phase

Not provided

Conditions

Primary Progressive Multiple Sclerosis

Interventions

Ocrelizumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Jul 18, 2023

First Submission Date that Met QC Criteria

Aug 2, 2023

First Posted Date

Aug 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2024

Last Update Posted Date

Sep 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Zivadinov, MD, PhD, Principal Investigator, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Name	Class
Genentech, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

732Actual

Name	Type	Description	Arm Group Labels	Other Names
Ocrelizumab	Other	Non-interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cortical lesion number accumulation	Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.	5 years

Secondary Outcomes

Measure	Description	Time Frame
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.	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Primary Progressive Multiple Sclerosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Buffalo Neuroimaging Analysis Center		Buffalo	New York	14203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020528	Multiple Sclerosis, Chronic Progressive

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C533411	ocrelizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided