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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Physician standard-of-care

• Study Type: Observational
• Enrollment (Actual): 71

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; All participants enrolled	Drug: Physician standard-of-care; Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Record of treatment strategy followed	Week 0 to 2 years
Change in the CDAI score during the observational period	Week 0 to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of surgeries and hospitalizations during the observational period	Week 0 to 2 years

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Crohn's disease; Crohn Disease; standard-of-care; Active Crohn's Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: P06484