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Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment60% Female53.3%% White81.7%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T72Data PartnerJohnson & JohnsonCondition StudiedColitis, UlcerativeMean/Median Age (Years)14.5
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
- 2022-5120 : Validation of an artificial intelligence model on central read endoscopic disease severity in patients with ulcerative colitis
- 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
- 2017-2306 : Continuing or Stopping 5-ASA in Biologic-Treated Patients with Moderate-Severe Ulcerative Colitis: A Post-Hoc Analysis of RCTs
- 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
- 2015-0612 : 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