Evidence map›Paper›PMID 30043658›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2019

Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study.

Jeffrey A Cohen, Giancarlo Comi, Douglas L Arnold, Amit Bar-Or, Krzysztof W Selmaj, Lawrence Steinman, Eva K Havrdová, Bruce Ac Cree, Xavier Montalbán, Hans-Peter Hartung and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01628393 (A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01628393 phase2 / phase3completednot on this map

A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

TypeinterventionalSponsorCelgeneRan2012 to 2016Enrolled258ConditionsRelapsing Multiple SclerosisArmsOzanimod, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jeffrey A CohenMellen Center for MS Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
Giancarlo ComiDepartment of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Douglas L ArnoldNeuroRx Research and Montreal Neurological Institute, McGill University, Montreal, QC, Canada.
Amit Bar-OrCenter for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Krzysztof W SelmajCenter for Neurology, Łódź, Poland.
Lawrence SteinmanDepartment of Neurology & Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, USA.
Eva K HavrdováDepartment of Neurology and Center for Clinical Neuroscience, First Faculty of Medicine, Charles University, Prague, Czech Republic.
Bruce Ac CreeUCSF Weill Institute for Neurosciences and Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.
Xavier MontalbánDivision of Neurology and St. Michael's Hospital, University of Toronto, Toronto, ON, Canada/Cemcat, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain.
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
Vivian HuangBiostatistics, Celgene Corporation, San Diego, CA, USA.
Paul FrohnaClinical Development, Celgene Corporation, San Diego, CA, USA.
Brett E SkolnickClinical Development, Celgene Corporation, San Diego, CA, USA.
Ludwig KapposNeurologic Clinic and Polyclinic, University Hospital of Basel and University of Basel, Basel, Switzerland.
RADIANCE Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOzanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5.

objectiveEvaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis.

methodsIn the RADIANCE Part A phase II study (NCT01628393), participants with relapsing multiple sclerosis were randomized (1:1:1) to once-daily ozanimod hydrochloride (0.5 or 1 mg) or placebo. After 24 weeks, participants could enter a 2-year, dose-blinded extension. Ozanimod-treated participants continued their assigned dose; placebo participants were re-randomized (1:1) to ozanimod hydrochloride 0.5 or 1 mg (equivalent to ozanimod 0.46 and 0.92 mg).

resultsA total of 223 (89.6%) of the 249 participants completed the blinded extension. At 2 years of the extension, the percentage of participants who were gadolinium-enhancing lesion-free ranged from 86.5% to 94.6%. Unadjusted annualized relapse rate during the blinded extension (week 24-end of treatment) was 0.32 for ozanimod hydrochloride 0.5 mg → ozanimod hydrochloride 0.5 mg, 0.18 for ozanimod hydrochloride 1 mg → ozanimod hydrochloride 1 mg, 0.30 for placebo → ozanimod hydrochloride 0.5 mg, and 0.18 for placebo → ozanimod hydrochloride 1 mg. No second-degree or higher atrioventricular block or serious opportunistic infection was reported.

conclusionOzanimod demonstrated sustained efficacy in participants continuing treatment up to 2 years and reached similar efficacy in participants who switched from placebo; no unexpected safety signals emerged.

Indexed as

Outcome Assessment, Health CareAdolescentAdultDouble-Blind MethodFemaleHumansIndansMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingOxadiazolesSphingosine 1 Phosphate Receptor ModulatorsYoung AdultIndansOxadiazolesozanimodSphingosine 1 Phosphate Receptor ModulatorsClinical trialdisease-modifying therapiesMRImultiple sclerosisrelapsing/remittingT2 lesions

Identifiers

PMID30043658
PMCPMC6681431

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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.