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NCT01551290
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Primary Citation
Trial has yet to be published
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Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment99% FemaleN/A% WhiteN/A
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberCR018769; REMICADEUCO3001Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)37
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
- 2023-5194 : 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
- 2022-4949 : 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
- 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
- 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
- 2015-0677 : 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