- CSR Summary Not Yet Available
- NCT01604343
- Primary Citation
- Data Specification Not Available
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Trial Information
Generic NameSirukumabProduct NamePLIVENSIATherapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment1670% Female79.9%% White72.3%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO136ARA3002Data PartnerJohnson & JohnsonCondition StudiedArthritis, RheumatoidMean/Median Age (Years)52.9
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
- 2024-0356 : Combining clinical trials with external data: applications in the YODA database
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2022-5060 : A meta-analysis to assess relationships between patient demographics and response to antibody-based treatment in rheumatoid arthritis patients
- 2020-4454 : Inferential reproducibility of therapeutic research: a registered report for a cross-sectional study of RCTs available on major data-sharing platforms
- 2019-4015 : Justification of PROMIS (FACIT) Fatigue Short Form 10a scale for FDA Drug Development Tool Qualification in Rheumatoid Arthritis