Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab

Conditions

Multiple Sclerosis, Relapsing

Brief summary

Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.

Lilyana Amezcua, Nancy Monson, Mitzi Williams, Timothy Vartanian, Anthony T. Reder et al. (14 authors)

Neurology2024-04-092 citations

10.1212/wnl-.0000000000205282

Demographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial.

Williams MJ, Okai AF, Cross AH, Monson NL, Vartanian T, Thrower BW, Reder AT, English JB, Wu GF, Bernitsas E, Yap S, Ndrio J, Pei J, Mowry EM, Magrini F, Acosta J, Amezcua L, CHIMES investigators.

2023-06-098 citations

10.1016/j.msard.2023.104794

An Interim Analysis of Efficacy and Safety Data in Black and Hispanic Patients With Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial (S31.006)

Evanthia Bernitsas, Anthony T. Reder, Ángel Chinea, Craig Herrman, Barbara O’Brien et al. (13 authors)

Neurology2023-04-25

10.1212/wnl.0000000000203125

Diversity, inclusion, and patient (pt)-centricity in the randomized, double-blind, phase III ASTEFANIA study of ado-trastuzumab emtansine (T-DM1) ± atezolizumab in pts with HER2-positive early breast cancer (EBC) with residual invasive disease after preoperative chemotherapy and anti-HER2 therapy.

Sarah Rogerson, Howard W. Turner, Angela Bilkhu, Estefanía Monturus, Adam Knott et al. (18 authors)

Journal of Clinical Oncology2022-06-011 citations

10.1200/jco.2022.40.16_suppl.e12504

Demographics and Baseline Disease Characteristics of Black and Hispanic Patients With Multiple Sclerosis in the CHIMES Trial (P4-4.005)

Lilyana Amezcua, Annette F. Okai, Anne H. Cross, Nancy Monson, Ben Thrower et al. (15 authors)

Neurology2022-05-031 citations

10.1212/wnl.98.18_supplement.3257

Interventions

DRUGOcrelizumab

Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment * Participants who self-identify as Black or African American or Hispanic/Latino American * Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab * Neurologically stable for at least 30 days prior to randomization and baseline assessments

Exclusion criteria

* Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS) * Primary Progressive Multiple Sclerosis (PPMS) * Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure * Infection Related * Cancer Related * Pregnant or lactating, or intending to become pregnant during the study * Other Medical Conditions * Known presence or history of other neurologic disorders * Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab * Laboratory: abnormalities or findings at screening

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment	48 Weeks	A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)

Secondary

Measure	Time frame	Description
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48	Week 48	—
Time to protocol-defined event	Week 48	A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI
Annualized relapse rate at week 48	Week 48	—

Countries

Kenya, Puerto Rico, United States

Contacts

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed