Trial reportAnnals of neurology2018
Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial.
Trial report in Annals of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01194570 (A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis), which is not on this map. Cited by 22 papers, 2 of them syntheses 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.
A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.
- Immunomodulators and immunosuppressants for progressive multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- Ocrelizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2022Pooled it
- Chronic white matter lesion activity predicts clinical progression in primary progressive multiple sclerosis.Brain : a journal of neurology · 2019Trial
- Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial.Multiple sclerosis (Houndmills, Basingstoke, England) · 2018Trial
- Societal Versus Healthcare Perspectives on the Cost Effectiveness of Ocrelizumab for Treatment of Primary Progressive Multiple Sclerosis in Aotearoa New Zealand.PharmacoEconomics · 2025Article
- AI-assisted identification of disability patterns within identical EDSS grades.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Article
- Measuring Disease Progression in Multiple Sclerosis Clinical Drug Trials and Impact on Future Patient Care.CNS drugs · 2025Review
- Sensor-Derived Measures of Motor and Cognitive Functions in People With Multiple Sclerosis Using Unsupervised Smartphone-Based Assessments: Proof-of-Concept Study.JMIR formative research · 2024Article
- Toxicokinetics of a humanized anti-cocaine monoclonal antibody in male and female rats and lack of cross-reactivity.Human vaccines & immunotherapeutics · 2023Review
- Diagnosis and treatment of progressive multiple sclerosis: A position paper.European journal of neurology · 2023Review
- A Narrative Review on Axonal Neuroprotection in Multiple Sclerosis.Neurology and therapy · 2022Review
- Does Ocrelizumab Limit Multiple Sclerosis Progression? Current Evidence from Clinical, MRI, and Fluid Biomarkers.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022Review
- Serum contactin-1 as a biomarker of long-term disease progression in natalizumab-treated multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2022Article
- Measuring Treatment Response in Progressive Multiple Sclerosis-Considerations for Adapting to an Era of Multiple Treatment Options.Biomolecules · 2021Review
- Identifying multiple sclerosis subtypes using unsupervised machine learning and MRI data.Nature communications · 2021Article
- Pain in Multiple Sclerosis: Understanding Pathophysiology, Diagnosis, and Management Through Clinical Vignettes.Frontiers in neurology · 2021Review
- Deciphering Multiple Sclerosis Progression.Frontiers in neurology · 2021Review
- Role of B Cells in Multiple Sclerosis and Related Disorders.Annals of neurology · 2021Review
- [Ocrelizumab for treatment of multiple sclerosis].Der Nervenarzt · 2020Review
- Epidemiology and treatment of multiple sclerosis in elderly populations.Nature reviews. Neurology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveNo evidence of progression or active disease (NEPAD) is a novel combined endpoint defined by the absence of both progression and inflammatory disease activity in primary progressive multiple sclerosis (PPMS). In the placebo-controlled phase III ORATORIO study (NCT01194570), we investigated the effect of ocrelizumab on this comprehensive outcome and its components in a post-hoc analysis.
methodsThe proportion of patients with NEPAD (no evidence of progression [NEP; no 12-week confirmed progression of ≥1/≥0.5 points on the Expanded Disability Status Scale if the baseline score was ≤5.5/>5.5 points, respectively; no 12-week confirmed progression of ≥20% on the Timed 25-Foot Walk test and 9-Hole Peg Test], no brain magnetic resonance imaging activity [no new/enlarging T2 lesions and no T1 gadolinium-enhancing lesions], and no protocol-defined relapse) from baseline to week 120 was determined in ocrelizumab- (600 mg; n = 465) and placebo-treated (n = 234) patients.
resultsThe majority of ORATORIO study patients with PPMS experienced clinical progression or evidence of disease activity. From baseline to week 120, 29.9% and 42.7% ocrelizumab-treated compared to 9.4% and 29.1% placebo-treated patients maintained NEPAD (relative risk [95% confidence interval {CI}], 3.15 [2.07-4.79]; p < 0.001) and NEP (relative risk [95% CI], 1.47 [1.17-1.84]; p < 0.001), respectively. Effects on the individual components of both measures were consistent with the compound outcomes.
interpretationCompared to placebo, ocrelizumab enhanced 3-fold the proportion of PPMS patients with no evidence of either progression or inflammatory disease activity. NEPAD may represent a sensitive and meaningful comprehensive measure of disease control in patients with PPMS. Ann Neurol 2018;84:527-536.
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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.