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Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaDigestive System DiseasesEnrollment1228% Female43%% White82.4%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T18Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)40.3
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
- 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
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2023-5251 : Efficient Learning of Continuous-Time Hidden Markov Models with Discrete-Time Irregular Observations for Healthcare Intervention Planning
- 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
- 2023-5195 : 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
- 2022-5120 : 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
- 2022-5012 : The Relationship between The Time to Achieve Clinical or Biomarker Remission and Long-term Outcomes in Inflammatory Bowel Disease
- 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
- 2022-4882 : Impact of Steroid Weaning Regimens on Outcomes in Clinical Trials of Ulcerative Colitis
- 2021-4848 : Responsiveness of the UC-100 Score in Patients with Moderately to Severely Active Ulcerative Colitis
- 2021-4829 : Placebo Rates in Inflammatory Bowel Disease: An Individual Patient Data Meta-analysis of Randomized Controlled Trials
- 2021-4779 : Predictors of Placebo Response and Remission in Ulcerative Colitis and Crohn's Disease
- 2020-4397 : Methods for Staging disease activity In ulcerative colitis; A comparison of endoscopy and Histology (MESIAH)
- 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
- 2018-3765 : Predictors of therapeutic and adverse effect outcomes of golimumab
- 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
- 2017-2306 : Continuing or Stopping 5-ASA in Biologic-Treated Patients with Moderate-Severe Ulcerative Colitis: 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
- 2015-0677 : Meta-analysis: Duration of inflammatory bowel disease and its impact on efficacy of biologic drugs
- 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