Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaDigestive System DiseasesEnrollment508% Female48.4%% White92.8%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T67Data 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
- 2024-0808 : Making Effectiveness Research better by meta-analysing Trial and Real World Evidence in Immune-Mediated inflammatory Diseases (MERMAID)
- 2021-4602 : Modified Multiplier SES-CD (MM-SES-CD) on Predicting Endoscopic Remission in Crohn's Disease
- 2020-4234 : Patient Reported Outcomes in Crohn?s Disease: A Post-hoc Analysis of the SONIC Trial
- 2019-4107 : Efficacy of biologic drugs in short-duration versus long-duration inflammatory bowel disease: individual-patient level meta-analysis
- 2019-3980 : Impact of Ulcer Size and Extent of Inflammation On Ability To Achieve Endoscopic Healing In Crohn's Disease: A SONIC post hoc Analysis
- 2015-0556 : Operating Characteristics of Centrally-Read Endoscopic Indices and a Novel Patient Reported Outcome Measure for Crohn's Disease
- 2015-0522 : Impact of infliximab concentrations on combination therapy for Crohn's disease
- 2014-0401 : Can Machine Learning Algorithms using General Labs Predict Biologic Remission for Patients on Thiopurines in the SONIC trial?