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Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment297% Female46.8%% White92.9%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberREMICADECRD3001Data PartnerJohnson & JohnsonCondition StudiedCrohn's DiseaseMean/Median Age (Years)34
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
- 2022-5013 : Identification of the Need for Hematopoietic Stem Cell Transplantation in Crohn's Disease Patients: A Ma-chine Learning Approach
- 2020-4474 : Comparison of the Rutgeert's score with the SES-CD for prediction of post-operative clinical recurrence in Crohn?s disease
- 2020-4341 : Estimating the association between TNF inhibitors and Legionnaires' disease and Listeriosis: A Meta-analysis
- 2019-4067 : Evidence-generation for biologics in pediatric studies
- 2018-3737 : Gender-based Differences in Response to Therapy in Inflammatory Bowel Disease
- 2018-3476 : Efficacy of Crohn?s Disease Treatment Stratified by Disease Phenotype
- 2018-3236 : Thiopurines versus anti-TNFa for the prevention of postoperative recurrence in Crohn?s disease ? a meta-analysis of individual patient data
- 2017-1856 : Impact of Age on Safety and Efficacy of Biologic Therapy for Inflammatory Bowel Disease
- 2016-1046 : Serum infliximab concentration and prevention of clinical or endoscopic post-operative recurrence after an ileocolonic resection for Crohn's disease
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials