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)

NCT ID: NCT01218360

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-01-31

Brief 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.

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants

All participants enrolled

Physician standard-of-care

Intervention Type: DRUG

Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).

Interventions

Physician standard-of-care

Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P06484

Identifier Type: -

Identifier Source: org_study_id