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NCT03248024 Clinical Trial

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

Inflammatory Bowel Diseases Clinical Trial

— FECPEC MICI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03248024
Other study ID # FECPEC MICI
Secondary ID
Status Completed
Phase N/A
First received August 9, 2017
Last updated August 9, 2017
Start date November 28, 2016
Est. completion date February 7, 2017

Study information
Verified date July 2017
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date February 7, 2017
Est. primary completion date February 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Central Hospital, Nancy, France HEVA - Lyon

Outcome
Type Measure Description Time frame Safety issue
Primary Retrospective health care consumption Desease treatment cost individual level data one year
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