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)

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01218360

Enrollment

Registered

2010-10-11

Start date

2011-11-30

Completion date

2015-01-31

Last updated

2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

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

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.

Interventions

DRUGPhysician standard-of-care

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	Week 0
Record of treatment strategy followed	Week 0 to 2 years
Change in the CDAI score during the observational period	Week 0 to 2 years

Secondary

Measure	Time frame
Number of surgeries and hospitalizations during the observational period	Week 0 to 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026