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CSR Summary
Not Yet Available
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NCT01604343
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Primary Citation
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Trial Information
Generic NameSirukumabProduct NamePLIVENSIATherapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupInterleukin InhibitorsCondition StudiedArthritis, Rheumatoid
Sponsor Protocol NumberCNTO136ARA3002Enrollment1670Data PartnerJohnson & Johnson% Female79.9%Mean/Median Age (Years)52.9% White72.3%
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
- 2026-0352 : Early Prediction of Treatment Response in Rheumatoid Arthritis Using Patient-Reported Outcomes
- 2025-0868 : Predictors of Placebo Response in Randomized Controlled Trials of Biologic DMARDs for RA, PsA, and SpA
- 2024-0356 : Combining clinical trials with external data: applications in the YODA database
- 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
