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)

August 9, 2017 updated by: Central Hospital, Nancy, France

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective health care consumption
Time Frame: one year
Desease treatment cost individual level data
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

HEVA - Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2016

Primary Completion (Actual)

February 7, 2017

Study Completion (Actual)

February 7, 2017

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FECPEC MICI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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