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Completed

NCT Number: NCT03248024

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

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

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Key information

Conditions

Inflammatory Bowel Diseases Chronic Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients consulted at the Gastroenterology services of Nancy University Hospital during the period of inclusion
  • Patients over 18 of age the day of consultation
  • Patients treated at least one time by biotherapy during the last 12 months preceeding inclusion
  • Patients with crohn's disease or ulcerative colitis.
  • 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

Treatment and study plan

Primary outcomes

  1. Retrospective health care consumption

    Time frame: one year

    Desease treatment cost individual level data

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • HEVA - Lyon

Registry information

Official study 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

Acronym: FECPEC MICI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2017
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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