At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)
In Brief
An observational study evaluating CT-P13 and Remicade for Inflammatory Bowel Diseases and 2 related conditions. Completed, enrolled 2,565 participants across 140 sites in 13 countries.
Detailed Summary
This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: * To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade * To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade * To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
Study Details
Timeline
Interventions
biosimilar infliximab
infliximab