An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

TerminadoFase 3ClinicalTrials.gov

ID: NCT03085810Tipo: INTERVENTIONALInicio: 24 de mar de 2017Fin estimado: 27 de abr de 2023

Traducción no disponible, mostrando original

Resumen

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 55 YearsSexo: ALL

Criterios de inclusión

Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
Have a length of disease duration, from first documented clinical attack consistent with MS disease of less than or equal to (\</=) 3 years
Within the last 12 months one or more clinically reported relapse(s) or one or more signs of MRI activity
EDSS of 0.0 to 3.5 inclusive, at screening
An agreement to use an acceptable birth control method for women of childbearing potential, during the treatment period and for at least 6 months or longer after the last dose of study drug

Criterios de exclusión

Known presence of other neurological disorders
Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
Inability to complete an MRI
Exclusions Related to General Health:
Pregnancy or lactation
Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
History or currently active primary or secondary immunodeficiency
Lack of peripheral venous access
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study
Congestive heart failure (New York Heart Association III or IV functional severity)
Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
History of malignancy, major opportunistic infections, alcohol or drug abuse, recurrent or chronic infection, and/or coagulation disorders
Exclusions Related to Medications:
Received any prior approved disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone marrow transplantation)
Treatment with investigational DMT
Treatment with fampridine/dalfamipridine unless on stable dose for \>/=30 days prior to screening
Exclusion related to Shorter Infusion Substudy:
\- Any previous serious IRRs experienced with ocrelizumab treatment

Intervenciones

drug

Ocrelizumab

Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Ubicaciones

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

Buenos Aires, Argentina

Hospital Churruca Visca

Buenos Aires, Argentina

Fundacion Rosarina de Neurorehabilitacion

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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