- CSR Summary Not Yet Available
- NCT02181673
- Primary Citation
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Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment480% Female48.1%% WhiteN/A
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO148PSA3001Data PartnerJohnson & JohnsonCondition StudiedArthritis, RheumatoidMean/Median Age (Years)46.2
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
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- 2022-5060 : A meta-analysis to assess relationships between patient demographics and response to antibody-based treatment in rheumatoid arthritis patients
- 2020-4341 : Estimating the association between TNF inhibitors and Legionnaires' disease and Listeriosis: A Meta-analysis
- 2019-4067 : Evidence-generation for biologics in pediatric studies
- 2018-3765 : Predictors of therapeutic and adverse effect outcomes of golimumab
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials