A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)

Crohn Disease Clinical Trial

— PREMONITION-CD  

Official title:

Characterization of a Multidimensional Model to Predict the Course of Crohn's Disease: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668249
• Other study ID #: IBD-5002
• Secondary ID: U1111-1220-0873
• Status: Completed
• Start date: September 26, 2018
• Est. completion date: September 16, 2019

Study information

• Verified date: October 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. The clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. The predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the Autonomous Community of Madrid, capable of assigning any participant diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.

Description:

This is a retrospective and non-interventional study of participants with CD. The study will collect data from electronic medical records (EMRs) of the participants in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of EMRs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with CD. This study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site.

The study will have a retrospective data collection from EMRs of the participants referring to last 5 years.

The study will enroll approximately 3000 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Spain. The overall time for data collection in the study will be approximately 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5938
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with CD from the medical centers participating in the study.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Spain	HM Hospitales	Boadilla	Madrid
Spain	H. U. de Fuenlabrada	Fuenlabrada	Madrid
Spain	H La Princesa	Madrid
Spain	H.U. Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	H.U. Rey Juan Carlos	Mostoles	Madrid
Spain	H.U. Infanta Sofia	San Sebastian de Los Reyes	Madrid
Spain	H. U. Infanta Elena	Valdemoro	Madrid
Spain	H Infanta Leonor y Virgen de la Torre	Vallecas	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who had Relapses		Approximately 5 years
Primary	Number of Participants who had Disease Related Complications		Approximately 5 years
Primary	Number of day Hospital Visits		Approximately 5 years
Primary	Number of Participants who had Surgeries		Approximately 5 years
Primary	Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas		approximately 5 years
Primary	Participant Flow		Approximately 5 years
Primary	Number of Participants who Visit to Other Specialists		Approximately 5 years
Secondary	Prevalence of the Different Phenotypes	Development of a statistical predictive model capable of assigning any patient diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.	Approximately 5 years
Secondary	Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD		Approximately 5 years
Secondary	Number of Direct and Indirect Resources Used	Health care resources of participants with CD will be assessed in terms of direct and indirect resources. Direct resources will include number of hospital admissions, emergency and hospital visits, and tests performed, etc. Indirect resources related to decreased productivity of CD participants through a specific variable, the total number of work days lost due to CD during the study period.	Approximately 5 years
Secondary	Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based		Approximately 5 years