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Eine Studie zu Ocrelizumab bei Teilnehmenden mit schubförmig remittierender Multipler Sklerose, die auf eine adäquate krankheitsmodifizierende Behandlung suboptimal angesprochen haben
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
- Autoimmunerkrankung
- Multiple Sklerose (MS)
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Augsburg
- Berg
- Berlin
- Bochum
- Bonn
- Buchholz in der Nordheide
- Böblingen
- Dresden
- Düsseldorf
- Erbach
- Frankfurt am Main
- Freiburg im Breisgau
- Hamburg
- Hannover
- Heidelberg
- Hennigsdorf
- Itzehoe
- Kassel
- Leipzig
- Magdeburg
- Mainz
- Marburg
- München
- Münster
- Neuruppin
- Oldenburg in Holstein
- Potsdam
- Stuttgart
- Tübingen
- Ulm
- Westerstede
Studien-ID:
NCT02861014 2015-005597-38 MA30005
Studienzusammenfassung
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02861014,MA30005,2015-005597-38
Studien-ID
Ocrelizumab
Treatments
Multiple Sclerosis, Relapsing-Remitting
Condition
Official Title
An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
Einschlusskriterien
All
Gender
≥18 Years & ≤ 55 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
- Have a length of disease duration, from first symptom, of less than (<) 10 years
- Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
- Suboptimal disease control while on a DMT
- Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
- For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
Exclusion Criteria
- Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
- Inability to complete an Magnetic Resonance Imaging (MRI) procedure
- Known presence of other neurological disorders
- 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
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of opportunistic infections
- History or known presence of recurrent or chronic infection
- History of malignancy
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
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