Retrospective Data Analysis in Crohn's Disease

The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.

Completed

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site, Ehrenfelsstraße 47, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

therapeutic need according to SPC
written informed consent

Treatment and study plan

Primary outcomes

Response to Mesalazine: measured by time to step up therapy

Time frame: 12 to 48 months

Secondary outcomes

Identification and characterisation of the responding sub-population

Time frame: 12 to 48 months

measured by: (a) Age at diagnosis, (b) Proportion of patients with minor endoscopic lesions, (c) Lack of severe mucosal lesions (Adapted Rutgeerts Score < 2)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries

Acronym: Crohn 2

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jun 1, 2011
Registry last updated: Jun 1, 2011

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.

Published trials that share one or more normalized conditions with this study.

Completed