- CSR Summary Not Yet Available
- NCT01230827
- Primary Citation
Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment173% Female75.7%% WhiteN/A
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO148JIA3001Data PartnerJohnson & JohnsonCondition StudiedArthritis, JuvenileMean/Median Age (Years)11.2
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
- 2023-5446 : Bayesian nonparametric methods for pediatric extrapolation
- 2022-4888 : Dose reduction and discontinuation of disease modifying anti-rheumatic drugs (DMARDs) for juvenile idiopathic arthritis
- 2019-4067 : Evidence-generation for biologics in pediatric studies
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials