Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)

Crohn Disease Clinical Trial

Official title:

Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218360
• Other study ID #: P06484
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: March 18, 2015
• Start date: November 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece : National Organization of Medicine EOF, Department of Clinical Trials
• Study type: Observational

Clinical Trial Summary

This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

1. Must have a diagnosis of active Crohn's Disease irrespective of severity,

2. Must be inadequately controlled with their current therapy and for whom physician

decides to switch treatment.

3. Must be between 18 and 65 years of age, of either sex,

4. Must demonstrate willingness to participate in the study by signing the written informed consent.

Exclusion Criteria

• No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Physician standard-of-care
Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Crohn's disease participants among the study population with a Crohn's Disease Activity Index (CDAI) score of 220-450 at the enrollment to the study.		Week 0	No
Primary	Record of treatment strategy followed		Week 0 to 2 years	No
Primary	Change in the CDAI score during the observational period		Week 0 to 2 years	No
Secondary	Number of surgeries and hospitalizations during the observational period		Week 0 to 2 years	No