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

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ClinicalTrials.gov Identifier: NCT02861118
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Other: No Intervention

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.

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Study Type : Observational
Actual Enrollment : 310 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease: VERNE Study
Actual Study Start Date : October 26, 2016
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : April 4, 2018

Group/Cohort Intervention/treatment
Cohort 1: Crohn's Disease
Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.
Other: No Intervention
Cohort 2: Ulcerative Colitis
Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
Other: No Intervention



Primary Outcome Measures :
  1. Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy [ Time Frame: Up to 10 weeks after start of treatment with biologics ]
    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.

  2. Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy [ Time Frame: Up to 6 months after start of treatment with biologics ]
    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.


Secondary Outcome Measures :
  1. Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy [ Time Frame: Up to 10 weeks after start of treatment with biologics ]
    Correlation between extraintestinal manifestations profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of at least 2 points from baseline in HBI score for CD or PMS for UC after 10 weeks treatment with 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.

  2. Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy [ Time Frame: Up to 6 months after start of treatment with biologics ]
    Correlation between extraintestinal manifestations profile and loss of response, adjusted for sociodemographic and clinical profile, 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.

  3. Percentage of IBD Participants With Comorbidities [ Time Frame: Day 1 ]
    Participants with CD and UC along with comorbidities were reported. Comorbidity referred to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition.

  4. Percentage of CD Participants With Comorbidities According to the Level of IBD Severity [ Time Frame: Day 1 ]
    Participants with CD were classified into IBD severe or non-severe at baseline based on the HBI scores according the following criteria:- HBI includes general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease.

  5. Percentage of UC Participants With Comorbidities According to the Level of IBD Severity [ Time Frame: Day 1 ]
    Participants with UC were classified into IBD severe or non-severe at baseline based on the PMS scores according the following criteria:- PMS score includes 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 is sum of sub scale scores ranging from 0=normal to 9=severe disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861118


Locations
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Spain
Santiago de Compostela, A Coruna, Spain
Huesca, Aragon, Spain
Gijon, Asturias, Spain
Alcazar de San Juan, Ciudad Real, Spain
Girona, Gerona, Spain
Las Palmas, Gran Canaria, Spain
Alcorcon, Madrid, Spain
Fuenlabrada, Madrid, Spain
Parla, Madrid, Spain
Pamplona, Navarra, Spain
Vigo, Pontevedra, Spain
Castellon de la Plana, Valencia, Spain
Sagunto, Valencia, Spain
Barakaldo, Vizcaya, Spain
Barcelona, Spain
Burgos, Spain
Ciudad Real, Spain
Madrid, Spain
Murcia, Spain
Santander, Spain
Sevilla, Spain
Valencia, Spain
Valladolid, Spain
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Statistical Analysis Plan  [PDF] February 15, 2017
Study Protocol  [PDF] April 13, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02861118    
Other Study ID Numbers: Vedolizumab-5016
First Posted: August 10, 2016    Key Record Dates
Results First Posted: August 14, 2019
Last Update Posted: August 14, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis