A5010821086- Monoclonal and Polyclonal Antibodies Research
- Multiple Sclerosis Research Studies
- Statistical Methods in Clinical Trials
- T-cell and B-cell Immunology
- Bioinformatics and Genomic Networks
- Health Systems, Economic Evaluations, Quality of Life
- CAR-T cell therapy research
- Immunotherapy and Immune Responses
- RNA Interference and Gene Delivery
- Polyomavirus and related diseases
- Viral Infections and Immunology Research
- Biosimilars and Bioanalytical Methods
- 14-3-3 protein interactions
- Amyotrophic Lateral Sclerosis Research
- Skin and Cellular Biology Research
Novartis (Switzerland)
2020-2022
Novartis (United States)
2022
Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS). Objective: To demonstrate bioequivalence of ofatumumab administered by an autoinjector versus a pre-filled syringe (PFS) and to explore effect on B-cell depletion. Methods: APLIOS (NCT03560739) 12-week, open-label, parallel-group, phase-2 study patients with RMS receiving subcutaneous 20 mg every 4 weeks (q4w) (from Week 4, after initial doses...
Optimizing new drug therapies remains a challenge for clinical development, despite the use of ever more sophisticated quantitative methodologies. Although conceptually simple, idea finding right treatment at dose patient to ensure an appropriate balance risks and benefits is challenging requires multidisciplinary approach. In this paper, we present framework developed as tool organizing knowledge facilitating collaboration in development teams.
Abstract This article describes a novel mixed‐scaling testing strategy, in combination with an adaptive parallel‐groups bioequivalence trial, to test pharmacokinetic equivalence of two formulations drug highly variable pharmacokinetics. The methodology was applied the Phase 2 APLIOS study relapsing multiple sclerosis patients, where subcutaneous ofatumumab 20 mg administered via autoinjector pen (test formulation) versus prefilled syringe (reference abdomen has been studied. Due high...
Several studies have described prognostic value of serum neurofilament light chain (sNfL) at the group level in relapsing multiple sclerosis (RMS) patients. Here, we aimed to explore temporal association between sNfL and development subclinical disease activity as assessed by magnetic resonance imaging (MRI) evaluate potential a biomarker for capturing individual RMS In 12-week APLIOS study, patients (N = 284) received subcutaneous ofatumumab 20 mg. Frequent sampling (14 time points over 12...
Objective: To evaluate the onset of ofatumumab 20 mg subcutaneous (s.c) effect on B-cell depletion and suppression magnetic resonance imaging (MRI) activity in relapsing multiple sclerosis (RMS) patients. Background: B cells play a major role pathogenesis MS. Ofatumumab, first fully human anti-CD20 monoclonal antibody with monthly s.c. dosing regimen suppressed 94–98% gadolinium-enhancing (Gd+) lesions versus teriflunomide Phase 3 ASCLEPIOS I/II trials. In APLIOS, MRI scans, action can be...
To explore the value of a biosignature combined plasma neurofilament light chain (pNfL) and glial fibrillary acidic protein (pGFAP) as prognostic marker disability worsening in secondary progressive multiple sclerosis (SPMS).