Trial Information
Generic NameUstekinumabProduct NameSTELARA®Therapeutic AreaDigestive System DiseasesEnrollment1309% Female56.4%% White84.9%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCNTO1275CRD3003Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)36
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
- 2024-0888 : Assessing the Impact of Disease Duration on the Likelihood of Healing in the Ileum and Colon in Crohn’s Disease
- 2024-0868 : Analysis of Treatment Response and Inclusion in Large-Scale Biologic Therapy Trials Across Age Groups in Inflammatory Bowel Disease (TRIAGE-IBD)
- 2024-0792 : The effect of frailty and old age on the efficacy and safety of advanced therapies in inflammatory bowel disease: A pooled analysis of individual pati
- 2024-0460 : Dynamics of Disease Activity in Monitoring Therapeutic Outcomes and Predicting Prognosis for Crohn’s disease
- 2024-0428 : Development of an Inflammatory Bowel Disease (IBD) patient population dashboard to monitor and improve care through machine learning
- 2024-0356 : Combining clinical trials with external data: applications in the YODA database
- 2023-5212 : Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2023-5194 : Determining Endoscopic Treatment Response in Ulcerative Colitis and Crohn's Disease using the Win Probability Approach
- 2022-5021 : Correlation Between Symptoms and Objective Measures of Disease Activity in Patients with Moderate to Severe Ulcerative Colitis and Crohn?s Disease
- 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
- 2021-4822 : Comparative Efficacy of Ustekinumab and Infliximab on One Year Outcomes Among Biologic-nave Induction Responders in Crohn's Disease
- 2021-4779 : Predictors of Placebo Response and Remission in Ulcerative Colitis and Crohn's Disease
- 2021-4778 : Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease
- 2021-4684 : Dominant Patient Reported Outcomes on Predicting Mucosal Healing in Crohn's Disease
- 2021-4602 : Modified Multiplier SES-CD (MM-SES-CD) on Predicting Endoscopic Remission in Crohn's Disease
- 2020-4535 : Development of a Novel Disease Activity Index for Crohn?s Disease
- 2020-4529 : Endoscopic Disease Severity and Patient Reported Outcomes in Crohn's Disease
- 2020-4499 : Serum cytokines in predicting outcomes to ustekinumab in patients with Crohn?s disease
- 2020-4416 : Comparative Efficacy of Ustekinumab and Infliximab on Clinical and Endoscopic Outcomes in Crohn?s Disease
- 2020-4363 : Predictors of Endoscopic Healing in Crohn's Disease: A Post-hoc Analysis of the UNITI and IM-UNITI Trials
- 2020-4362 : Impact of Baseline Strictures on Clinical and Endoscopic Outcomes in Crohn's Disease
- 2019-4104 : Effectiveness of Ustekinumab on Arthritis/Arthralgia in Crohn's Disease: post hoc Analysis of UNITI
- 2019-4105 : The Impact of Body Mass Index on the Efficacy of Ustekinumab in the IM-UNITI Trial
- 2019-4026 : The Role of Fecal Calprotectin in Predicting Clinical Remission and Mucosal Healing in 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
- 2017-1746 : Heterogeneity in relative treatment efficacy by age, sex, socioeconomic status and comorbidity
- 2016-1176 : Can Machine Learning Algorithms Using General Labs Predict Biologic Remission for Patients on ustekinumab?
- 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