Mechanistic Study of Ocrevus | NCT04459988

Studies
Mechanistic Study of Ocrevus

NCT04459988

Sponsor

University of Michigan

Status

Completed

Last Update Posted

May 31, 2024Actual

Enrollment

35Actual

Phase

Not provided

Conditions

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

May 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

Jul 1, 2020Actual

Primary Completion Date

Oct 25, 2022Actual

Completion Date

Oct 25, 2022Actual

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jul 2, 2020

First Posted Date

Jul 7, 2020Actual

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

May 29, 2024

Last Update Posted Date

May 31, 2024Actual

Description Module

Brief Summary

The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. The goal of the study is to understand the role of regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.

Detailed Description

Not provided

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

Retention

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with MS		Patients with MS who have been newly prescribed Ocrevus	Drug: Ocrelizumab
Healthy Controls		Healthy Controls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ocrelizumab	Drug	Description Needed	Patients with MS	Ocrevus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in frequency of regulatory B cells	Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls	From baseline to 24 months

Secondary Outcomes

Measure	Description	Time Frame
Change in frequency of T cell subtypes	Percentage of T cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls	From baseline to 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with MS either with relapsing or primary progressive course; who are newly starting on ocrelizumab (Ocrevus) at the time of enrollment

Healthy controls who do not have a significant medical conditions such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.

Ability to give informed consent
Willing to have blood drawn as scheduled in the protocol
Willing and able to complete all procedures and evaluations related to the study

Exclusion Criteria:

Medical or psychiatric conditions that may affect the patient's ability to give informed consent
Has received an experimental drug within 30 days of enrollment
Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate, azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus, etc.)
Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study
Active hepatitis B virus infection
History of life-threatening infusion reaction to Rituxan or Ocrevus
Chronic infection or any severe acute infection within 3 months prior to screening

Accepts Healthy Volunteers

Yes

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

The study will recruit 25 MS patients (Group 1; include 5-10 PPMS and 15-20 RRMS). Meanwhile, 10 healthy controls (Group 2; HCs) will be recruited to establish baseline immune cell profiles. The patients and healthy controls will be recruited at the University of Michigan Neurology Clinic.

Sampling Method

Non-Probability Sample

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases