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CSR Summary
Not Yet Available
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NCT00488774
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Primary Citation
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Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaDigestive System DiseasesEnrollment291% Female40.2%% White82.1%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T16Data 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
- 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
- 2022-5013 : 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
- 2022-4975 : Impact of concomitant baseline medication on efficacy of biologics and small molecules for Inflammatory Bowel Disease
- 2022-4949 : Precision Medicine for Patients with Ulcerative Colitis Using Synthetic Controls
- 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
- 2020-4341 : Estimating the association between TNF inhibitors and Legionnaires' disease and Listeriosis: A Meta-analysis
- 2019-4092 : Cross-Trial Comparisons of Biologic Therapies for Auto-Immune Diseases
- 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
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials