{"status":"OK","data":{"id":462828,"identifier":"6NSZ3H","persistentUrl":"https://doi.org/10.34894/6NSZ3H","protocol":"doi","authority":"10.34894","separator":"/","publisher":"DataverseNL","publicationDate":"2025-01-27","storageIdentifier":"surf://10.34894/6NSZ3H","effectiveDatasetFileCountLimit":10000,"datasetFileUploadsAvailable":10000,"datasetType":"dataset","locks":[],"latestVersion":{"id":29988,"datasetId":462828,"datasetPersistentId":"doi:10.34894/6NSZ3H","datasetType":"dataset","storageIdentifier":"surf://10.34894/6NSZ3H","versionNumber":1,"internalVersionNumber":8,"versionMinorNumber":0,"versionState":"RELEASED","latestVersionPublishingState":"RELEASED","deaccessionLink":"","productionDate":"2018-02-02","lastUpdateTime":"2025-01-27T08:02:59Z","releaseTime":"2025-01-27T08:02:59Z","createTime":"2024-12-11T14:08:37Z","publicationDate":"2025-01-27","citationDate":"2025-01-27","effectiveDatasetFileCountLimit":10000,"datasetFileUploadsAvailable":10000,"license":{"name":"CC0-1.0","uri":"http://creativecommons.org/publicdomain/zero/1.0","iconUri":"https://licensebuttons.net/p/zero/1.0/88x31.png","rightsIdentifier":"CC0-1.0","rightsIdentifierScheme":"SPDX","schemeUri":"https://spdx.org/licenses/","languageCode":"en"},"fileAccessRequest":true,"metadataBlocks":{"citation":{"displayName":"Citation Metadata","name":"citation","fields":[{"typeName":"title","multiple":false,"typeClass":"primitive","value":"Intravenous immunoglobulin combined with intravenous methylprednisolone versus intravenous immunoglobulin only as induction treatment in chronic inflammatory demyelinating polyradiculoneuropathy: a randomised, double-blind, placebo-controlled, phase 3 study."},{"typeName":"alternativeTitle","multiple":true,"typeClass":"primitive","value":["OPTIC-trial"]},{"typeName":"author","multiple":true,"typeClass":"compound","value":[{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Bus, Sander"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"amsterdamumc.nl"}}]},{"typeName":"datasetContact","multiple":true,"typeClass":"compound","value":[{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"F. Eftimov"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"amsterdamumc.nl"}}]},{"typeName":"dsDescription","multiple":true,"typeClass":"compound","value":[{"dsDescriptionValue":{"typeName":"dsDescriptionValue","multiple":false,"typeClass":"primitive","value":"Background\nIntravenous immunoglobulin (IVIg) and corticosteroids are considered first-line but alternative induction treatments for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). We aimed to establish if combining these induction treatments led to more frequent remissions from CIDP than IVIg alone.\n\nMethods\nWe conducted a randomised, double-blind, placebo-controlled study in people with CIDP. Participants were allocated in a 1:1 ratio to receive either intravenous methylprednisolone (IVMP, 1000 mg) or placebo, both administered in combination with IVIg every three weeks for a total of 18 weeks. The primary outcome was remission, defined as sustained improvement on disability scales at 52 weeks without need for further treatment. Analyses were performed in the intention-to-treat and per-protocol datasets. Secondary outcomes included between group differences on eight outcome measures at 18 weeks and at endpoint compared with baseline. Study was registered with the ISRCTN registry (ISRCTN15893334).\n\nFindings \nInclusion was stopped prematurely after inclusion of 77 of 96 planned participants because of safety concerns, as four thromboembolic events occurred in the IVMP group compared with none in the placebo group. Thirty-seven participants had been assigned to receive IVMP and 40 to receive placebo at termination. Fourteen (38%) participants in the IVMP group were in remission at 52 weeks compared with 11 (28%) in the placebo group, with a difference of 10% (95% CI -11 to 31, p=0·47). There was no statistically significant difference in the proportion of participants improving during 18 weeks of treatment or in total number of adverse events. Secondary outcomes demonstrated greater magnitude of improvement in the IVMP group compared to placebo. \n\nInterpretation\nCombined treatment with IVIg and IVMP did not lead to more frequent remissions than treatment with IVIg alone. The IVMP group appeared to have greater magnitude of improvement on secondary outcome measures, but a potentially higher risk of thromboembolic events."}}]},{"typeName":"subject","multiple":true,"typeClass":"controlledVocabulary","value":["Medicine, Health and Life Sciences"]},{"typeName":"keyword","multiple":true,"typeClass":"compound","value":[{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)"},"keywordVocabulary":{"typeName":"keywordVocabulary","multiple":false,"typeClass":"primitive","value":"CIDP"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"Intravenous immunoglobulin"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"Intravenous methylprednisolone"}}]},{"typeName":"topicClassification","multiple":true,"typeClass":"compound","value":[{"topicClassValue":{"typeName":"topicClassValue","multiple":false,"typeClass":"primitive","value":"Randomised controlled trial"}}]},{"typeName":"publication","multiple":true,"typeClass":"compound","value":[{"publicationCitation":{"typeName":"publicationCitation","multiple":false,"typeClass":"primitive","value":"Main trial manuscript submitted"}}]},{"typeName":"notesText","multiple":false,"typeClass":"primitive","value":"As of yet unpublished"},{"typeName":"language","multiple":true,"typeClass":"controlledVocabulary","value":["English"]},{"typeName":"productionDate","multiple":false,"typeClass":"primitive","value":"2018-02-02"},{"typeName":"productionPlace","multiple":true,"typeClass":"primitive","value":["AMC"]},{"typeName":"contributor","multiple":true,"typeClass":"compound","value":[{"contributorType":{"typeName":"contributorType","multiple":false,"typeClass":"controlledVocabulary","value":"Project Leader"},"contributorName":{"typeName":"contributorName","multiple":false,"typeClass":"primitive","value":"F. Eftimov"}},{"contributorType":{"typeName":"contributorType","multiple":false,"typeClass":"controlledVocabulary","value":"Data Manager"},"contributorName":{"typeName":"contributorName","multiple":false,"typeClass":"primitive","value":"Meriem Manaï"}}]},{"typeName":"grantNumber","multiple":true,"typeClass":"compound","value":[{"grantNumberAgency":{"typeName":"grantNumberAgency","multiple":false,"typeClass":"primitive","value":"Prinses Beatrix Spierfonds"},"grantNumberValue":{"typeName":"grantNumberValue","multiple":false,"typeClass":"primitive","value":"W.OR17-03"}},{"grantNumberAgency":{"typeName":"grantNumberAgency","multiple":false,"typeClass":"primitive","value":"ZonMW"},"grantNumberValue":{"typeName":"grantNumberValue","multiple":false,"typeClass":"primitive","value":"848016011"}}]},{"typeName":"distributor","multiple":true,"typeClass":"compound","value":[{"distributorName":{"typeName":"distributorName","multiple":false,"typeClass":"primitive","value":"F. Eftimov"},"distributorAffiliation":{"typeName":"distributorAffiliation","multiple":false,"typeClass":"primitive","value":"Amsterdam UMC, location AMC"}}]},{"typeName":"depositor","multiple":false,"typeClass":"primitive","value":"Bus, Sander"},{"typeName":"dateOfDeposit","multiple":false,"typeClass":"primitive","value":"2024-12-11"},{"typeName":"timePeriodCovered","multiple":true,"typeClass":"compound","value":[{"timePeriodCoveredStart":{"typeName":"timePeriodCoveredStart","multiple":false,"typeClass":"primitive","value":"2018-02-02"},"timePeriodCoveredEnd":{"typeName":"timePeriodCoveredEnd","multiple":false,"typeClass":"primitive","value":"2024-02-16"}}]},{"typeName":"dateOfCollection","multiple":true,"typeClass":"compound","value":[{"dateOfCollectionStart":{"typeName":"dateOfCollectionStart","multiple":false,"typeClass":"primitive","value":"2018-02-02"},"dateOfCollectionEnd":{"typeName":"dateOfCollectionEnd","multiple":false,"typeClass":"primitive","value":"2024-02-16"}}]},{"typeName":"kindOfData","multiple":true,"typeClass":"primitive","value":["Clinical data"]},{"typeName":"series","multiple":true,"typeClass":"compound","value":[{"seriesInformation":{"typeName":"seriesInformation","multiple":false,"typeClass":"primitive","value":"Time period end date is an estimation (inclusion of last participant plus one year). Data regarding the long-term (2 year) follow-up is not inckluded in this dataset."}}]},{"typeName":"software","multiple":true,"typeClass":"compound","value":[{"softwareName":{"typeName":"softwareName","multiple":false,"typeClass":"primitive","value":"Castor EDC"}}]}]},"dansDataVaultMetadata":{"displayName":"Data Vault Metadata","name":"dansDataVaultMetadata","fields":[{"typeName":"dansDataversePid","multiple":false,"typeClass":"primitive","value":"doi:10.34894/6NSZ3H"},{"typeName":"dansDataversePidVersion","multiple":false,"typeClass":"primitive","value":"1.0"},{"typeName":"dansBagId","multiple":false,"typeClass":"primitive","value":"urn:uuid:3df3bfe2-2c9d-4635-acbb-cf6a33a04cb7"},{"typeName":"dansNbn","multiple":false,"typeClass":"primitive","value":"urn:nbn:nl:ui:13-5de16f82-b29f-4745-aa51-1ce7c6727983"}]}},"files":[]}}}