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An Explanatory Factors Analysis of Inflammatory Bowel Diseases(IBD's) Management Costs for Adults Patients Treated by Biotherapy and Followed at Nancy University Hospital (FECPEC MICI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03248024
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
HEVA - Lyon
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:
The objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative colitis

Condition or disease
Inflammatory Bowel Diseases

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Study Type : Observational
Actual Enrollment : 119 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Etude Des Facteurs Explicatifs Des Coûts de la Prise En Charge Des Patients Adultes Atteints d'Une MICI Suivis au CHRU de Nancy et traités Par biothérapie
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

Primary Outcome Measures :
  1. Retrospective health care consumption [ Time Frame: one year ]
    Desease treatment cost individual level data

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
Patients who received biotherapy during the last 12 months preceeding consultation for treatment of crohn's disease or ulcerative colitis.

Inclusion Criteria:

  1. Patients consulted at the Gastroenterology services of Nancy University Hospital during the period of inclusion
  2. Patients over 18 of age the day of consultation
  3. Patients treated at least one time by biotherapy during the last 12 months preceeding inclusion
  4. Patients with crohn's disease or ulcerative colitis.
  5. Patients accepting to respond to the questionnary

Exclusion Criteria:

  • Age under 18 years , the day of consultation
  • Patient that not accept or unable to complete the retrospective questionnary
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Responsible Party: Central Hospital, Nancy, France Identifier: NCT03248024    
Other Study ID Numbers: FECPEC MICI
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Chronic Disease
Ulcerative Colitis
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases