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

Takeda

Status

Completed

Conditions

Inflammatory Bowel Disease

Treatments

Other: No Intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT02861118

Vedolizumab-5016

Details and patient eligibility

About

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.

Full 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.

Enrollment

310 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult participants (aged ≥18).
Were diagnosed with UC or CD according to the "World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of inflammatory bowel disease (IBD) in 2010".
Who were naive to biologics that started treatment with biologics between June 2011 and June 2013.
Participants in whom biological treatment was prescribed according to clinical practice.
Who gave written informed consent.

Exclusion criteria

Were participating in a clinical trial during the study reference period.
Participant that, according to investigator's criteria was not capable to understand and fill in the study questionnaires or to give written informed consent.