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
1 other identifier
observational
310
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedStudy Start
First participant enrolled
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2018
CompletedResults Posted
Study results publicly available
August 14, 2019
CompletedAugust 14, 2019
July 1, 2019
1.4 years
August 5, 2016
April 2, 2019
July 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy
Correlation between co-morbidities profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of 2 points from baseline in Harvey-Bradshaw Indices (HBI) score for CD or Partial Mayo score (PMS) for UC after 10 weeks treatment with anti-tumour necrosis factor (TNF). HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease.
Up to 10 weeks after start of treatment with biologics
Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
Correlation between co-morbidities profile and loss of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease.
Up to 6 months after start of treatment with biologics
Secondary Outcomes (5)
Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy
Up to 10 weeks after start of treatment with biologics
Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
Up to 6 months after start of treatment with biologics
Percentage of IBD Participants With Comorbidities
Day 1
Percentage of CD Participants With Comorbidities According to the Level of IBD Severity
Day 1
Percentage of UC Participants With Comorbidities According to the Level of IBD Severity
Day 1
Study Arms (2)
Cohort 1: Crohn's Disease
Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.
Cohort 2: Ulcerative Colitis
Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (23)
Unknown Facility
Santiago de Compostela, A Coruna, Spain
Unknown Facility
Huesca, Aragon, Spain
Unknown Facility
Alcázar de San Juan, Ciudad Real, Spain
Unknown Facility
Girona, Gerona, Spain
Unknown Facility
Las Palmas, Gran Canaria, Spain
Unknown Facility
Alcorcón, Madrid, Spain
Unknown Facility
Fuenlabrada, Madrid, Spain
Unknown Facility
Parla, Madrid, Spain
Unknown Facility
Pamplona, Navarre, Spain
Unknown Facility
Vigo, Pontevedra, Spain
Unknown Facility
Gijón, Principality of Asturias, Spain
Unknown Facility
Castellon, Valencia, Spain
Unknown Facility
Sagunto, Valencia, Spain
Unknown Facility
Barakaldo, Vizcaya, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Burgos, Spain
Unknown Facility
Ciudad Real, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Murcia, Spain
Unknown Facility
Santander, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Valladolid, Spain
Related Publications (1)
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.
PMID: 32337054DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2016
First Posted
August 10, 2016
Study Start
October 26, 2016
Primary Completion
April 4, 2018
Study Completion
April 4, 2018
Last Updated
August 14, 2019
Results First Posted
August 14, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.