relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)
Conditions
Interventions
Ocrelizumab Group:intravenous infusion
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.RMS Cohort:; 2.Signed Informed Consent Form; 3.Ability to comply with the study protocol; 4.Age 18-55 years at the time of signing Informed Consent Form; 5.A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria and one of the following::1. At least two clinical relapses within the last 2 years or one clinical relapse within 12 months of screening (but not within the 30 days prior to screening); 2. Evidence of the presence of at least one T1 Gd+ lesion on MRI within 12 months prior to initiation of treatment; 6.Neurological stability for = 30 days before both screening and baseline assessment; 7.Expanded Disability Status Scale score from 0-5.5, inclusive, at screening and baseline; 8.Documented MRI of brain with abnormalities consistent with MS before screening; 9.For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab. 10.Women may be enrolled if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy) or post-menopausal (i.e., spontaneous amenorrhea for the past year confirmed by a follicle-stimulating hormone [FSH] level >40 mIU/mL) unless the participants is receiving a hormonal therapy for her menopause. 11.PPMS Cohort:; 12.Signed Informed Consent Form; 13.Ages 18-55 years at time of signing Informed Consent Form; 14.Ability to comply with the study protocol; 15.Diagnosis of PPMS, in accordance with the revised McDonald criteria 2017 (Thompson et al. 2018); 16.EDSS score at screening and baseline, from 3.0 to 6.5; 17.Documented MRI of brain with abnormalities consistent with MS; 18.Patients requiring symptomatic treatment for MS (e.g., fampridine, cannabis) and/or physiotherapy must be treated at a stable dose during the screening period prior to the initiation of study drug on Day 1 and must have a plan to remain at a stable dose for the duration of study treatment; 19.For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months (as applicable by the ocrelizumab [Ocrevus] local label) after the final dose of ocrelizumab. 20.Females may be enrolled if post-menopausal (i.e., spontaneous amenorrhea for the past year confirmed by a FSH level > 40 mIU/mL) unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).
Exclusion criteria
Exclusion criteria: 1.Diagnosis of PPMS or non-active SPMS (only for RMS cohort); 2.History of RRMS or SPMS at screening (only for PPMS cohort); 3.Disease duration of more than 10 years in participants with an EDSS= 2.0 at screening (only for RMS cohort); 4.Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening; 5.History of confirmed or suspected progressive multifocal leukoencephalopathy (PML); 6.History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. 7.Receipt of a live or live-attenuated vaccine within 6 weeks prior to initiation of treatment. 8.Inability to complete an MRI scan (contraindications for MRI scan, including but not restricted to, pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks of entry in the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI scan) or contraindication to Gd administration. 9.Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines) for IRRs, including uncontrolled psychosis for corticosteroids or closed-angle glaucoma for antihistamines. 10.Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study; 11.Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study; 12.Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study; 13.History or currently active primary or secondary (non-drug-related) immunodeficiency,including known history of HIV infection; 14.Pregnant or breastfeeding, or intention of becoming pregnant during the study or 6 months after the final dose of study drug. 15.Lack of peripheral venous access; 16.History of alcohol or drug abuse within 12 months prior to screening; 17.Treatment with any investigational agent within 24 weeks of screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer; or treatment with any experimental procedures for MS [e.g., treatment for chronic cerebrospinal venous insufficiency]); 18.Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening, B-cell count is normal at screening, and treatment discontinuation was not motivated by safety reasons or lack of efficacy; 19.Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab; 20.Previous use of fingolimod, siponimod, or ozanimod within 6 weeks of initiation of treatment or ponesimod within 4 weeks of initiation of treatment; 21.Previous treatment with natalizumab within 4.5 months of baseline; 22.Previous treatment with dimethyl fumarate, diroximel fumarate within 4 weeks of treatment initiation; 23.Previous treatment with IFN-ß (1a or 1b), or glatiramer acetate within 2 weeks of baseline; 24.Previous use of teriflunomide, unless = 24
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PPMS Group:PD biomarker;RMS Cohort:Protocol-defined relapse; | — |
Countries
China
Contacts
Public ContactYan Xu
Peking Union Medical College Hospital
Outcome results
None listed