- CSR Summary Not Yet Available
- NCT01004432
- Primary Citation
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Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment433% Female20.9%% WhiteN/A
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO148ART3002Data PartnerJohnson & JohnsonCondition StudiedArthritis, RheumatoidMean/Median Age (Years)55.7
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
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2023-5446 : Bayesian nonparametric methods for pediatric extrapolation
- 2022-5060 : A meta-analysis to assess relationships between patient demographics and response to antibody-based treatment in rheumatoid arthritis patients
- 2022-4951 : What are the re-identification risk scores of publicly available anonymised clinical trial datasets?
- 2021-4715 : Disease-modifying anti-rheumatic drugs for rheumatoid arthritis: A network meta-analysis incorporating individual patient data
- 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