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)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01218360

First received: October 7, 2010

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Crohn Disease	Drug: Physician standard-of-care

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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)

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
Record of treatment strategy followed [ Time Frame: Week 0 to 2 years ] [ Designated as safety issue: No ]
Change in the CDAI score during the observational period [ Time Frame: Week 0 to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of surgeries and hospitalizations during the observational period [ Time Frame: Week 0 to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria

Must have a diagnosis of active Crohn's Disease irrespective of severity,
Must be inadequately controlled with their current therapy and for whom physician decides to switch treatment.
Must be between 18 and 65 years of age, of either sex,
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01218360 History of Changes
Other Study ID Numbers:	P06484
Study First Received:	October 7, 2010
Last Updated:	January 16, 2013
Health Authority:	Greece : National Organization of Medicine EOF, Department of Clinical Trials

Keywords provided by Merck:

Crohn's disease
standard-of-care
Crohn Disease
Active Crohn's Disease

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 19, 2013

To Top