N/A
Completed N=310
A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease
Source: ClinicalTrials.gov NCT02861118 ↗Enrolled (actual)
310
Serious AEs
0.3%
Results posted
Aug 2019
Primary outcomePrimary: Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy — 0.59; 2.16; 2.67 odds ratio — p=0.024
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy |
0.59; 2.16; 2.67 | 0.024 sig |
| PRIMARY Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy |
0.58; 2.45; 3.30 | 0.044 sig |
| SECONDARY Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy |
2.08 | 0.007 sig |
| SECONDARY Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy |
2.57; 2.73 | 0.002 sig |
| SECONDARY Percentage of IBD Participants With Comorbidities |
2.2; 0.9; 1.6; 0.9; 1.6; 0.0 | — |
| SECONDARY Percentage of CD Participants With Comorbidities According to the Level of IBD Severity |
62.4; 8.3 | — |
| SECONDARY Percentage of UC Participants With Comorbidities According to the Level of IBD Severity |
37.6; 91.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02861118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.