Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment123% Female85.9%% White92.1%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T32Data 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
- 2019-4067 : Evidence-generation for biologics in pediatric studies
- 2015-0691 : Impact of Biologic Therapy on the Risk of Arterial and Venous Thromboembolic Events in Chronic Autoimmune Diseases: A Post-Hoc Analysis of RCTs
- 2015-0649 : Population Representativeness of Clinical Trial Study Samples
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials