Retrospective Data Analysis in Crohn's Disease

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT01363427
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2011-05
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-05-31
• Last Update Submitted: 2011-05-31
• Study First Posted: 2011-06-01
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• therapeutic need according to SPC
• written informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to Mesalazine: measured by time to step up therapy	12 to 48 months

Secondary Outcome Measures

Name	Time	Method
Identification and characterisation of the responding sub-population	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)

Trial Locations

Locations (16)

Investigational Site, Ehrenfelsstraße 47; 🇩🇪 Berlin, Germany

Investigational Site, Am Tiefen Weg 2; 🇩🇪 Karlstadt, Germany

Investigational Site, Münchner Straße 64; 🇩🇪 Dachau, Germany

Investigational Site, Hohenfelder Straße 20; 🇩🇪 Koblenz, Germany

Investigational Site, Graseggerstraße 105; 🇩🇪 Köln, Germany

Investigational Site, Franz-Kail-Straße 2; 🇩🇪 Leverkusen, Germany

Investigational Site, Uferstraße 3; 🇩🇪 Minden, Germany

Investigational Site, Erdbeerfeld 8; 🇩🇪 Kiel-Altenholz, Germany

Investigational Site, Bahnhofplatz 2; 🇩🇪 Mainz, Germany

Investigational Site, Funkenburgstraße 19; 🇩🇪 Leipzig, Germany

Investigational Site, Karlsbader Straße 7; 🇩🇪 Dinkelsbühl, Germany

Investigational Site, Heiligengrabstraße 16; 🇩🇪 Hof, Germany

Investigational Site, Möllendorfstraße 111; 🇩🇪 Berlin, Germany

Investigational Site, Weiltinger Str. 11; 🇩🇪 Nürnberg, Germany

Investigational Site, Hammer Straße 95; 🇩🇪 Münster, Germany

Investigational Site, Marktplatz 23; 🇩🇪 Rottenburg, Germany