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)

Merck Sharp & Dohme LLC71 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Crohn Disease

Interventions

Physician standard-of-careDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Record of treatment strategy followed

Time frame: Week 0 to 2 years

Change in the CDAI score during the observational period

Time frame: Week 0 to 2 years

Secondary Outcomes

Number of surgeries and hospitalizations during the observational period

Time frame: Week 0 to 2 years

Data from ClinicalTrials.gov

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