Last updated 43 hours ago
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
182 patients around the world
Available in Argentina, United States, Mexico, Brazil
Hoffmann-La Roche
10Research sites
182Patients around the world
This study is for people with
Multiple Sclerosis
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria or the most current McDonald criteria at the time of study start.Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening.
- Participants who have previously received anti-cluster of differentiation (CD)20s (including ocrelizumab) less than 2 years before screening.Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons.History of confirmed or suspected progressive multifocal leukoencephalopathy (PML).History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening.Immunocompromised state.Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab.History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study.Lack of peripheral venous access.Previous treatment with cladribine, atacicept, and alemtuzumab.Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation.Any previous history of transplantation or anti-rejection therapy.Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV).
Sites
CIER - Centro de Investigación en Enfermedades Reumáticas
Recruiting
Sanatorio del Sur - Tucumán
Recruiting
CENyR - Centro de especialidades neurológicas y rehabilitación
Recruiting
Centro Médico Focus - CECIC
Recruiting
INECO Neurociencias Oroño - Rosario
Recruiting
INC - Instituto de Neurologia de Curitiba
Recruiting
IMV Pesquisa Neurológica
Recruiting
CPClin – Centro de Pesquisas Clinicas LTDA
Recruiting
Innovación y Desarrollo en Ciencias de la Salud - IDeCSa
Recruiting
Neurociencias Estudios Clínicos S.C. - Culiacán
Recruiting
StudyPORTAMENTO
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Multiple Sclerosis
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07074886
