- CSR Summary Not Yet Available
- NCT01606761
- Primary Citation
- Data Specification Not Available
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Trial Information
Generic NameSirukumabProduct NamePLIVENSIATherapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment878% Female81.1%% White75.3%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO136ARA3003Data PartnerJohnson & JohnsonCondition StudiedArthritis, RheumatoidMean/Median Age (Years)55.4
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
- 2022-5060 : A meta-analysis to assess relationships between patient demographics and response to antibody-based treatment in rheumatoid arthritis patients
- 2019-4015 : Justification of PROMIS (FACIT) Fatigue Short Form 10a scale for FDA Drug Development Tool Qualification in Rheumatoid Arthritis
- 2018-3704 : Identifying factors related to high placebo response rates in patients with active rheumatoid arthritis despite prior treatment with biological agents