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Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaDigestive System DiseasesEnrollment103% Female44.7%% White89.3%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO148UCO2001Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)42
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0316 : Monthly test of form functionality
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- 2018-3737 : Gender-based Differences in Response to Therapy in Inflammatory Bowel Disease
- 2018-3556 : Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials