Crohn DiseaseNCT01218360
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 of Crohn Disease, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Physician standard-of-care
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy
Who may be able to join
- 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.
Who cannot join
- No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial
About this study
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)
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.
- Conditions
- Crohn Disease
- Being tested
- Physician standard-of-care
- Keywords
- Crohn's disease, standard-of-care, Crohn Disease, Active Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician standard-of-careDrug
Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).
| Study group | Role | What they receive |
|---|---|---|
| Participants | All participants enrolled Receives: Drug: Physician standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0
Record of treatment strategy followed
Measured: Week 0 to 2 years
Change in the CDAI score during the observational period
Measured: Week 0 to 2 years
Secondary outcomes (1)
Number of surgeries and hospitalizations during the observational period
Measured: Week 0 to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startNov 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218360
- Sponsor's protocol ID
- P06484
- Status last verified
- Mar 2015
- First submitted
- 7 Oct 2010
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01218360
- Acronym / sponsor ID
- P06484
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, standard-of-care, Crohn Disease, Active Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Drug: Physician standard-of-careAll participants enrolled |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician standard-of-careParticipants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC). | Drug | Participants |
Primary outcome
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
1 secondary outcome
Number of surgeries and hospitalizations during the observational period
Time frame: Week 0 to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.