Trial reportMultiple sclerosis and related disorders2020
Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis.
Trial report in Multiple sclerosis and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03085810 (An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Systematic Review of Safety and Efficacy of Second- and Third-Generation CD20-Targeting Biologics in Treating Immune-Mediated Disorders.Frontiers in immunology · 2021Pooled it
- Randomized Phase 1 Studies Evaluating the Safety, Tolerability, Pharmacokinetics, and Target Occupancy of Zampilimab in Healthy Participants.Clinical pharmacology in drug development · 2026Trial
- Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis.Annals of clinical and translational neurology · 2023Trial
- Optimizing Infusion Center Efficiency in Multiple Sclerosis: A Nursing Multicenter Survey on Organizational Impact of Ublituximab.Healthcare (Basel, Switzerland) · 2026Article
- Pharmacodynamics and Pharmacokinetics of Ublituximab Compared with Other Anti-CD20 Monoclonal Antibodies for Multiple Sclerosis Treatment.Current neuropharmacology · 2026Review
- Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis.Annals of clinical and translational neurology · 2025Article
- Navigating Recent Changes in Dosing Information: Dynamics of FDA-Approved Monoclonal Antibodies in Post-Marketing Realities.Clinical and translational science · 2025Review
- Key characteristics of anti-CD20 monoclonal antibodies and clinical implications for multiple sclerosis treatment.Journal of neurology · 2024Review
- Key characteristics of anti-CD20 monoclonal antibodies and clinical implications for multiple sclerosis treatment.Journal of neurology · 2024Review
- Direct transition from rapid-infusion originator to rapid-infusion biosimilar tumor necrosis factor inhibitor in children with inflammatory bowel disease: A case series.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2024Article
- Evaluating the Therapeutic Potential of Ublituximab in the Treatment of MS: Design, Development and Place in Therapy.Drug design, development and therapy · 2024Review
- Disease Modifying Strategies in Multiple Sclerosis: New Rays of Hope to Combat Disability?Current neuropharmacology · 2024Review
- Review
- Acute Effects of Ocrelizumab Infusion in Multiple Sclerosis Patients.International journal of molecular sciences · 2022Article
- Ocrelizumab: A Review in Multiple Sclerosis.Drugs · 2022Review
- Therapeutic Advances in Multiple Sclerosis.Frontiers in neurology · 2022Review
- Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis.Neurology · 2021Article
- Clinical Perspectives on the Molecular and Pharmacological Attributes of Anti-CD20 Therapies for Multiple Sclerosis.CNS drugs · 2021Review
- Fast and safe: Optimising multiple sclerosis infusions during COVID-19 pandemic.Multiple sclerosis and related disorders · 2021Article
Corrections and comments
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Authors and funding
19 authors at 15 institutions in 13 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOcrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). Shortening the 600 mg infusion to 2 hours reduces the total site stay from 5.5-6 hours (approved infusion duration including mandatory pre-medication and post-infusion observation) to 4 hours. The safety profile of shorter-duration ocrelizumab infusions was investigated using results from ENSEMBLE PLUS.
methodsENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early-stage relapsing-remitting MS received ocrelizumab 600 mg infusions every 24 weeks for 192 weeks. In ENSEMBLE PLUS, ocrelizumab 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration); the durations of the initial infusions (2×300 mg, 14 days apart) were unaffected. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first Randomized Dose.
resultsFrom November 1, 2018, to December 13, 2019, 745 patients were randomized 1:1 to the conventional or shorter infusion group. At the first Randomized Dose, 99/373 patients (26.5%) in the conventional and 107/372 patients (28.8%) in the shorter infusion group experienced IRRs. The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107). No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuations occurred. During the first Randomized Dose, 22/373 (5.9%) and 39/372 (10.5%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. Adverse events were consistent with the known safety profile of ocrelizumab.
conclusionThe rates and severity of IRRs were similar between conventional and shorter infusions. No new safety signals were detected. Shortening the infusion time to 2 hours reduces the total site stay time (including mandatory pre-medication/infusion/observation) from 5.5-6 hours to 4 hours, and may reduce patient and site staff burden. A short video summarizing the key results is provided in supplemental material.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.