Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment364% Female40%% White96%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T37Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)40
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
- 2024-0764 : Impact of Concomitant Steroid Use on Adverse Events in Ulcerative Colitis Clinical Trials
- 2024-0748 : Comparison of Onset of Efficacy of Therapies for Ulcerative Colitis Based on Patient Symptom Diary Data
- 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
- 2024-0356 : Combining clinical trials with external data: applications in the YODA database
- 2023-5486 : Incorporating external data in clinical trial setting using BART
- 2014-0287 : Post hoc analysis of the ACT-1 & ACT-2 trials to simulate individualized dosing regimens using a predictive model
- 2023-5250 : Biomarkers for predicting long-term outcomes in ulcerative colitis
- 2023-5249 : Biomarkers for predicting long-term outcomes in ulcerative colitis
- 2023-5217 : Biomarkers for predicting long-term outcomes in ulcerative colitis
- 2023-5212 : Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease
- 2023-5194 : Determining Endoscopic Treatment Response in Ulcerative Colitis and Crohn's Disease using the Win Probability Approach
- 2022-5120 : Validation of an artificial intelligence model on central read endoscopic disease severity in patients with ulcerative colitis
- 2022-5104 : Biomarkers for Predicting Long-term Outcomes in Ulcerative Colitis
- 2022-5037 : Estimating Differences in the Comparison of Outcomes in Clinical Trials for UC Patients using Patient-Level Data and Aggregated Data: Network Meta-Ana
- 2022-5013 : Identification of the Need for Hematopoietic Stem Cell Transplantation in Crohn's Disease Patients: A Ma-chine Learning Approach
- 2022-4981 : Efficacy of medical therapies for ulcerative colitis according to disease distribution: An individual patient data meta-analysis of RCTs
- 2022-4949 : Precision Medicine for Patients with Ulcerative Colitis Using Synthetic Controls
- 2022-4901 : A Prediction Model for Loss of Response in Ulcerative Colitis Patients Initially Responding to Infliximab Therapy After Induction.
- 2022-4882 : Impact of Steroid Weaning Regimens on Outcomes in Clinical Trials of Ulcerative Colitis
- 2021-4779 : Predictors of Placebo Response and Remission in Ulcerative Colitis and Crohn's Disease
- 2021-4757 : A Comparison of the Rapidity of Clinical Response between Infliximab and Tofacitinib for Ulcerative Colitis.
- 2021-4698 : Early clinical response to biologics and small molecules for moderate-to-severe ulcerative colitis: a network meta-analysis
- 2020-4457 : Comparative Effectiveness of Vedolizumab vs. Infliximab in Ulcerative Colitis
- 2020-4341 : Estimating the association between TNF inhibitors and Legionnaires' disease and Listeriosis: A Meta-analysis
- 2020-4318 : Enhancing inference from real-world data using externally-derived missing data models: a pilot study of Ulcerative Colitis
- 2019-4107 : Efficacy of biologic drugs in short-duration versus long-duration inflammatory bowel disease: individual-patient level meta-analysis
- 2019-4092 : Cross-Trial Comparisons of Biologic Therapies for Auto-Immune Diseases
- 2019-4067 : Evidence-generation for biologics in pediatric studies
- 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
- 2018-3121 : Speed of onset of infliximab and golimumab in patients with moderate-severely active ulcerative colitis: A Post-Hoc Analysis of RCTs
- 2018-3061 : Development of a Clinical Prediction Tool for Treatment Outcomes in Infliximab-treated Patients with Moderate-Severe Ulcerative Colitis
- 2017-2306 : Continuing or Stopping 5-ASA in Biologic-Treated Patients with Moderate-Severe Ulcerative Colitis: A Post-Hoc Analysis of RCTs
- 2017-2031 : Association between Patient-reported Outcomes and Endoscopic Healing in Ulcerative Colitis: A meta-analysis
- 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
- 2016-0919 : Comparative efficacy of biologics in resolving extraintestinal manifestations of IBD: a systematic review and meta-analysis
- 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
- 2015-0677 : Meta-analysis: Duration of inflammatory bowel disease and its impact on efficacy of biologic drugs
- 2015-0649 : Population Representativeness of Clinical Trial Study Samples
- 2015-0612 : Impact of Obesity on Disease Course and Response to Biologic Therapy in Inflammatory Bowel Disease: A Post-Hoc Analysis of RCTs
- 2015-0527 : Optimizing Infliximab in IBD: Developing a model to determine the optimal interval for monitoring infliximab concentrations
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials
- 2014-0334 : Gender Differences in Weight Gain in Patients with Inflammatory Bowel Disease Treated with Infliximab