Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment112% Female41.1%% White83.9%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T47Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)13.3
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Additional Information
CSR Summary for open-label extension available here
Approved Data Requests Associated with this Trial
- 2023-5212 : Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease
- 2022-5013 : Identification of the Need for Hematopoietic Stem Cell Transplantation in Crohn's Disease Patients: A Ma-chine Learning Approach
- 2019-4067 : Evidence-generation for biologics in pediatric studies
- 2019-3943 : Defining a therapeutic drug window for infliximab induction therapy in pediatric patients with moderate-to-severe Crohn's disease
- 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
- 2018-2746 : Early Infliximab Drug Exposure and Outcomes in Children with Crohn?s Disease
- 2016-1107 : The impact of anti-TNF drug levels on rates of fistula healing in individuals with Crohn?s Disease
- 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
- 2015-0501 : TOWARDS AN IMPROVED PEDIATRIC CROHN?S DISEASE ACTIVITY INDEX: INTEGRATING CLINICAL TRIAL AND REGISTRY DATA TO IDENTIFY KEY DRIVERS OF CHANGE
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials