- CSR Summary Not Available
- NCT02407236
- Primary Citation
- Data Specification Not Available
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Trial Information
Generic NameUstekinumabProduct NameSTELARA®Therapeutic AreaDigestive System DiseasesEnrollment961% FemaleN/A% WhiteN/A
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO1275UCO3001Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)41.7
Supporting Documentation
- Collected Datasets Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0448 : Dynamics of Disease Activity in Monitoring Therapeutic Outcomes and Predicting Prognosis for Ulcerative Colitis
- 2024-0428 : Development of an Inflammatory Bowel Disease (IBD) patient population dashboard to monitor and improve care through machine learning
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2023-5300 : Outcomes from induction using ustekinumab or vedolizumab among patients who have prior biologic intolerance vs biologic failure in UC and CD
- 2023-5194 : Determining Endoscopic Treatment Response in Ulcerative Colitis and Crohn's Disease using the Win Probability Approach
- 2022-5104 : Biomarkers for Predicting Long-term Outcomes in Ulcerative Colitis
- 2022-4960 : Patient-reported Symptoms, Endoscopic, and Histologic Predictors of Endoscopic Improvement in Ulcerative Colitis
- 2018-3556 : Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease