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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01218360
First received: October 7, 2010
Last updated: July 11, 2014
Last verified: July 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01218360     History of Changes
Other Study ID Numbers: P06484
Study First Received: October 7, 2010
Last Updated: July 11, 2014
Health Authority: Greece : National Organization of Medicine EOF, Department of Clinical Trials

Keywords provided by Merck Sharp & Dohme Corp.:
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 July 23, 2014