Crohn DiseaseNCT00705471
Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)
An observational study of Crohn Disease, run by Merck Sharp & Dohme LLC.
Trial summary
A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Sep 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The charts of subjects with fistulizing CD to be recorded for the time period for up to three years before and for one year after their initial infliximab infusion for comparison of health care costs and utilization prior to infliximab and post infliximab use.
Who may be able to join
- Treatment with infliximab for fistulizing CD.
- Administration of at least one infliximab infusion >=12 months before the chart review.
- 18 years of age or over (men and women).
Who cannot join
- Subjects not followed for a full year after their first infusion of infliximab.
- Subjects not followed for a full year prior to their first infusion of infliximab.
- Subjects who had participated in clinical studies during the data collection timeframe.
About this study
Official title: Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are targeted to participate in the study, each site is expected to provide 30-40 patient charts with a target of 108 charts total.
Read the detailed description
This study population was chosen from a non-probability sample.
- Conditions
- Crohn Disease
- Being tested
- Infliximab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Also called Remicade, SCH 215596
None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Because of the difficulty of finding subjects with exactly the same disease severity, information will be recorded for the time period for up to three years before and for one year after their initial infliximab infusion for comparison of health care costs and utilization prior to infliximab and post infliximab use. Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year.
Measured: 1 year
Secondary outcomes (1)
To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startApr 2005
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: Study stopped prematurely due to enrolment challenges.
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
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705471
- Sponsor's protocol ID
- P04204
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2008
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
- ClinicalTrials.gov ID
- NCT00705471
- Acronym / sponsor ID
- P04204
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped prematurely due to enrolment challenges.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Centocor, Inc.
- Study start
- Apr 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Jun 2008 (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.
A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are targeted to participate in the study, each site is expected to provide 30-40 patient charts with a target of 108 charts total.
Detailed description
This study population was chosen from a non-probability sample.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab | – | Biological: InfliximabBecause of the difficulty of finding subjects with exactly the same disease severity, information will be recorded for the time period for up to three years before and for one year after their initial infliximab infusion for comparison of health care costs and utilization prior to infliximab and post infliximab use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The charts of subjects with fistulizing CD to be recorded for the time period for up to three years before and for one year after their initial infliximab infusion for comparison of health care costs and utilization prior to infliximab and post infliximab use.
Key inclusion criteria (3 listed)
- Treatment with infliximab for fistulizing CD.
- Administration of at least one infliximab infusion >=12 months before the chart review.
- 18 years of age or over (men and women).
Key exclusion criteria (3 listed)
- Subjects not followed for a full year after their first infusion of infliximab.
- Subjects not followed for a full year prior to their first infusion of infliximab.
- Subjects who had participated in clinical studies during the data collection timeframe.
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 |
|---|---|---|
| InfliximabAlso: Remicade, SCH 215596None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study. | Biological | Infliximab |
Primary outcome
To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year.
Time frame: 1 year
1 secondary outcome
To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study stopped prematurely due to enrolment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Apr 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 was stopped early (reason given: Study stopped prematurely due to enrolment challenges.). Results are not available in the source record.
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?
To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year. (time frame: 1 year). 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 8 Apr 2015.