Development and Validation of a Comorbidity Index in Crohn's Disease

Crohn Disease Clinical Trial

— NEMO-Index  

Official title:

Development and Validation of a Comorbidity Index in Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05253378
• Other study ID #: 2021PI158
• Status: Recruiting
• Start date: April 4, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

1. Patients between 18 and 59 years old

2. Established diagnosis of CD with a minimum disease duration of 3 months

3. Disease considered by the treating gastroenterologist to have been stable for at least 3 months

Exclusion Criteria:

1. Subject unable to comply with study procedures

2. Surgery for CD 3 months prior to inclusion visit

Related Conditions & MeSH terms

• Crohn Disease

Locations

Country	Name	City	State
France	Laurent PEYRIN-BIROULET	Vandoeuvre-lès-Nancy
Italy	San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.	Probability of having an IBD disability index = 35 (i.e. moderate and severe disability).	Through study completion, an average of 3 years