NCT02861118

A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease

Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease: VERNE Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 310 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the impact of the co-morbidities profile on treatment response to biological therapy in inflammatory bowel disease (IBD) participants.

Detailed description

This was a retrospective, non-interventional, observational study that included participants diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013. The study looked at the impact of the co-morbidities on the treatment response in IBD participants. The study enrolled 310 patients included both UC and CD patients. This multicenter trial was conducted in Spain. Investigator collected retrospective data in a single visit from participants who started biologic treatment between June 2011 and June 2013. Time since participants started biological treatment until study visit or until lack of treatment response or until treatment change constituted the reference period for the study.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
OTHER	No Intervention

Timeline

• Start date: 2016-10-26
• Primary completion: 2018-04-04
• Completion: 2018-04-04
• First posted: 2016-08-10
• Last updated: 2019-08-14
• Results posted: 2019-08-14

Locations

23 sites across 1 country: Spain