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CompletedNCT01218360Updated Mar 19, 2015

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)

An observational study in Crohn Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Merck Sharp & Dohme LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
71
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Crohn Disease

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Keywords

  • Crohn's disease
  • standard-of-care
  • Crohn Disease
  • Active Crohn's Disease
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 71 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

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

Exclusion Criteria

  • No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
71 participants (actual)

Groups and cohorts

  • Participants

    All participants enrolled

    Drug: Physician standard-of-care

Interventions

  • DrugPhysician standard-of-care

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01218360
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Oct 11, 2010
Start date
Nov 2011
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Mar 19, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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