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Completed

NCT Number: NCT01218360

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 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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physician standard-of-care

Drug

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

Primary outcomes

  1. 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

  2. Record of treatment strategy followed

    Time frame: Week 0 to 2 years

  3. Change in the CDAI score during the observational period

    Time frame: Week 0 to 2 years

Secondary outcomes

  1. Number of surgeries and hospitalizations during the observational period

    Time frame: Week 0 to 2 years

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2010
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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