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Trial Information
Generic NameUstekinumabProduct NameSTELARA®Therapeutic AreaDigestive System DiseasesEnrollment526% Female58.7%% White93.2%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0743T26Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)38
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
- 2023-5212 : Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease
- 2023-5145 : Improving efficiency of immune-mediated inflammatory disease trials through better design and analysis
- 2022-5013 : Identification of the Need for Hematopoietic Stem Cell Transplantation in Crohn's Disease Patients: A Ma-chine Learning Approach
- 2022-5012 : The Relationship between The Time to Achieve Clinical or Biomarker Remission and Long-term Outcomes in Inflammatory Bowel Disease
- 2021-4829 : Placebo Rates in Inflammatory Bowel Disease: An Individual Patient Data Meta-analysis of Randomized Controlled Trials
- 2019-3842 : Defining a therapeutic drug window following induction ustekinumab therapy in patients with active fistulizing Crohn?s disease.
- 2018-3743 : The impact of biological interventions on health?related quality of life in adults with Crohn's disease
- 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
- 2018-3476 : Efficacy of Crohn?s Disease Treatment Stratified by Disease Phenotype
- 2018-3131 : Treatment outcomes with biologics in moderate-severely active Crohn's disease stratified by ileal vs. colonic disease location
- 2018-3126 : Concomitant 5-ASA in Biologic-Treated Patients with Moderate-Severe Crohn?s Disease: A Post-Hoc Analysis of RCTs
- 2017-1856 : Impact of Age on Safety and Efficacy of Biologic Therapy for Inflammatory Bowel Disease
- 2016-0919 : Comparative efficacy of biologics in resolving extraintestinal manifestations of IBD: a systematic review and meta-analysis
- 2015-0612 : Impact of Obesity on Disease Course and Response to Biologic Therapy in Inflammatory Bowel Disease: A Post-Hoc Analysis of RCTs
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials