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Studie zur Beurteilung der Wirksamkeit und Sicherheit von Ocrelizumab bei Teilnehmenden mit schubförmig remittierender Multipler Sklerose (RRMS) im Frühstadium
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Autoimmunerkrankung Multiple Sklerose (MS) schubförmige remittierende MS
Basisinformationen
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Studien-ID
NCT03085810, MA30143, 2016-002937-31
Condition
Multiple Sclerosis, Relapsing-Remitting
Official Title
An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Einschlusskriterien
All
≥ 18 Years & ≤ 55 Years
No
Inclusion Criteria
- 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
Exclusion Criteria
- Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
- Inability to complete an MRI
- Known presence of other neurological disorders
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
Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.
Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.
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Studienergebnisse
LPS MA30143 ENSEMBLE Final Results September 2023 German
(PDF, 0.7 MB)
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