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Published on: December 9, 2015
Ocrelizumab in Early-Stage Relapsing-Remitting Multiple Sclerosis: The Phase IIIb ENSEMBLE 4-Year, Single-Arm,
Hans-Peter Hartung1, Ralph H B Benedict1, Thomas Berger1
1From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany; Brain and Mind Centre (H.-P.H.), University of Sydney, Australia; Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic; Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY; Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria; Mellen Center for MS (R.A.B.), Cleveland Clinic, OH; Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France; Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands; Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada; Department of Neurology (T.H.), Akershus University Hospital, Lørenskog; Institute of Clinical Medicine (T.H.), University of Oslo, Norway; Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey; Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy; Loyola University Chicago (A.P.R.), IL; Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium; Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora; Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel; F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland; and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands.
Ocrelizumab effectively treated early relapsing-remitting multiple sclerosis (RRMS) in treatment-naive patients over four years, significantly reducing disease activity and maintaining a favorable safety profile. This suggests ocrelizumab is a viable first-line therapy for newly diagnosed RRMS.
Area of Science:
- Neuroimmunology
- Clinical Neurology
- Pharmacology
Background:
- Early treatment of multiple sclerosis (MS) is crucial for reducing disease activity and long-term progression.
- Ocrelizumab's effectiveness is established in relapsing MS (RMS), but data in early RMS as a first-line therapy were limited.
- The ENSEMBLE study aimed to evaluate the long-term effectiveness and safety of ocrelizumab in treatment-naive patients with early relapsing-remitting MS (RRMS).
Purpose of the Study:
- To assess the 4-year effectiveness of ocrelizumab as a first-line treatment in patients with early RRMS.
- To evaluate the safety profile of ocrelizumab in this specific patient population.
- To determine the proportion of patients achieving no evidence of disease activity (NEDA-3) and other key clinical and MRI outcomes.
Main Methods:
- A prospective, 4-year, single-arm, open-label, phase IIIb study (ENSEMBLE) involving treatment-naive patients with early-stage RRMS.
- Patients received intravenous ocrelizumab 600 mg every 24 weeks.
- Effectiveness was measured by NEDA-3 (no relapses, 24-week confirmed disability progression [CDP], and MRI activity), annualized relapse rate (ARR), CDP, disability improvement, and changes in Expanded Disability Status Scale (EDSS) score.
Main Results:
- At 192 weeks, a significant proportion of patients (66.4%) achieved NEDA-3, with 90.9% experiencing no relapses and 81.8% having no 24-week CDP.
- The adjusted ARR was low (0.020), and serum neurofilament light chain (NfL) levels decreased to within the healthy donor range.
- No new or unexpected safety signals were observed, consistent with ocrelizumab's known safety profile.
Conclusions:
- Ocrelizumab treatment over 4 years resulted in sustained low disease activity in most treatment-naive patients with early RRMS.
- The observed safety profile was consistent with established data for ocrelizumab.
- The positive benefit-risk profile suggests ocrelizumab can be considered for first-line treatment in newly diagnosed patients with early RMS.
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