Clinical trial NCT02861118: A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease
Official title: Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease: VERNE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-08-10
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ulcerative colitis (UC) and Crohn's disease (CD) participants who started treatment with biologics between June 2011 and June 2013 will participate in the study.

Brief 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.

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.

Primary outcomes:
measure: Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy
timeFrame: Up to 10 weeks after start of treatment with biologics
measure: Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
timeFrame: Up to 6 months after start of treatment with biologics
Secondary outcomes:
measure: Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy
timeFrame: Up to 10 weeks after start of treatment with biologics
measure: Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
timeFrame: Up to 6 months after start of treatment with biologics
measure: Percentage of IBD Participants With Comorbidities
timeFrame: Day 1
measure: Percentage of CD Participants With Comorbidities According to the Level of IBD Severity
timeFrame: Day 1
measure: Percentage of UC Participants With Comorbidities According to the Level of IBD Severity
timeFrame: Day 1
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
state: A Coruna
city: Huesca
country: Spain
state: Aragon
city: Gijon
country: Spain
state: Asturias
city: Alcazar de San Juan
country: Spain
state: Ciudad Real
city: Girona
country: Spain
state: Gerona
city: Las Palmas
country: Spain
state: Gran Canaria
city: Alcorcon
country: Spain
state: Madrid
city: Fuenlabrada
country: Spain
state: Madrid
city: Parla
country: Spain
state: Madrid
city: Pamplona
country: Spain
state: Navarra
city: Vigo
country: Spain
state: Pontevedra
city: Castellon de la Plana
country: Spain
state: Valencia
city: Sagunto
country: Spain
state: Valencia
city: Barakaldo
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Ciudad Real
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Marin-Jimenez I, Bastida G, Fores A, Garcia-Planella E, Arguelles-Arias F, Sarasa P, Tagarro I, Fernandez-Nistal A, Montoto C, Aguas M, Santos-Fernandez J, Bosca-Watts MM, Ferreiro R, Merino O, Aldeguer X, Cortes X, Sicilia B, Mesonero F, Barreiro-de Acosta M. Impact of comorbidities on anti-TNFalpha response and relapse in patients with inflammatory bowel disease: the VERNE study. BMJ Open Gastroenterol. 2020 Mar 26;7(1):e000351. doi: 10.1136/bmjgast-2019-000351. eCollection 2020.