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Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassImmunosuppressantsPharmacological SubgroupImmunosuppressantsChemical SubgroupTumor Necrosis Factor Alpha (TNF-α) InhibitorsCondition StudiedColitis, Ulcerative
Sponsor Protocol NumberCNTO148UCO2001Enrollment103Data PartnerJohnson & Johnson% Female44.7%Mean/Median Age (Years)42.0% White89.3%
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
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- 2025-0496 : Development and Validation of Multi-Scale AI Foundation Models for Personalized Drug Response Prediction in Type 2 Diabetes and Ulcerative Colitis
- 2025-0404 : Data-sharing, reanalysis and sensitivity analysis of OS and PFS of pivotal randomized controlled trials in oncology
- 2025-0344 : Estimating heterogeneous treatment effects of biologic disease modifying drugs from multiple clinical trials in Juvenile Idiopathic Arthritis
- 2025-0332 : Urinary Tract Infection and Immune-Checkpoint therapy efficacy in Bladder Cancer: a systematic review and meta-analysis
- 2022-5120 : Validation of an artificial intelligence model on central read endoscopic disease severity in patients with ulcerative colitis
- 2022-5013 : Identification of the Need for Hematopoietic Stem Cell Transplantation in Crohn's Disease Patients: A Machine Learning Approach
- 2018-3737 : Gender-based Differences in Response to Therapy in Inflammatory Bowel Disease
- 2018-3556 : Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials
