-
CSR Summary Not Yet Available
-
NCT01230827
-
Primary Citation
-
You are not logged in.
Please login to continue selecting trials.
Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupTumor Necrosis Factor Alpha (TNF-α) InhibitorsCondition StudiedArthritis, Juvenile
Sponsor Protocol NumberCNTO148JIA3001Enrollment173Data PartnerJohnson & Johnson% Female75.7%Mean/Median Age (Years)11.2% WhiteN/A
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