Crohn's DiseaseTREATNCT00553176
The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry
An observational study of Crohn's Disease, run by Janssen Biotech, Inc..
Trial summary
The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 6,273 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to May 2012
- 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: Adult patients diagnosed with Crohn's Disease
Who may be able to join
- Patients must be diagnosed with Crohn's Disease
Who cannot join
- Patients participating in clinical trials for Crohn's disease or other conditions also were not eligible to be enrolled in the TREAT™ Registry
- Patients who are unable to participate in the program for 2 years or more.
About this study
Official title: Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry
The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.
Read the detailed description
The TREAT (The Crohn's Therapy, Resource, Evaluation, and Assessment Tool) registry is a prospective, observational, multicenter, long-term registry featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease. The physicians will track treatments and patient outcomes over at least a 5-year period. Physicians are expected to manage patients as they would under normal practice conditions. No predefined schedule of visits or medical procedures are required. Data are collected on a semi-annual basis by physicians documenting assessment of disease severity, medication use, and adverse events. Upon enrollment, patients complete a health assessment questionnaire. As this is an observational study, no study drugs are administered. Through the course of the Registry, analyses will be performed to support submissions to health authorities, and questions of academic interest.
- Conditions
- Crohn's Disease
- Being tested
- No intervention
- Keywords
- Infliximab, Immune disorder, Remicade, Registry, Crohn's Disease
- Medical subject headings
- Crohn Disease, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
At six-month intervals (January and July), physicians will document disease characteristics, changes in Crohn's therapy, disease progression, key events, the use of ancillary services, and hospitalizations
| Study group | Role | What they receive |
|---|---|---|
| Patients with Crohn's disease | The Registry is an observational research program featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the variety of treatment regimens currently employed in the management of Crohn's disease
Measured: Five years
Secondary outcomes (4)
To assess clinical, economic, and humanistic outcomes of treatment
Measured: Five years
To assess the long-term impact of various Crohn's disease treatment regimens
Measured: Five years
To assess long-term outcomes specifically associated with the use of Remicade
Measured: Five years
Collection of adverse events
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startAug 1999
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Biotech, Inc. Clinical Trial, Study director, Janssen Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553176
- Sponsor's protocol ID
- CR014140
- Other IDs
- WIRB® 990474
- Acronym
- TREAT
- Status last verified
- Mar 2013
- First submitted
- 1 Nov 2007
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry
- ClinicalTrials.gov ID
- NCT00553176
- Acronym / sponsor ID
- TREAT / CR014140
- Conditions
- Crohn's Disease
- Keywords
- Infliximab, Immune disorder, Remicade, Registry, Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,273 participants (actual)
- Lead sponsor
- Janssen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Nov 2007 (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.
The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.
Detailed description
The TREAT (The Crohn's Therapy, Resource, Evaluation, and Assessment Tool) registry is a prospective, observational, multicenter, long-term registry featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease. The physicians will track treatments and patient outcomes over at least a 5-year period. Physicians are expected to manage patients as they would under normal practice conditions. No predefined schedule of visits or medical procedures are required. Data are collected on a semi-annual basis by physicians documenting assessment of disease severity, medication use, and adverse events. Upon enrollment, patients complete a health assessment questionnaire. As this is an observational study, no study drugs are administered. Through the course of the Registry, analyses will be performed to support submissions to health authorities, and questions of academic interest.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Crohn's disease | – | Other: No interventionThe Registry is an observational research program featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with Crohn's Disease
Key inclusion criteria (1 listed)
- Patients must be diagnosed with Crohn's Disease
Key exclusion criteria (2 listed)
- Patients participating in clinical trials for Crohn's disease or other conditions also were not eligible to be enrolled in the TREAT™ Registry
- Patients who are unable to participate in the program for 2 years or more.
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 |
|---|---|---|
| No interventionAt six-month intervals (January and July), physicians will document disease characteristics, changes in Crohn's therapy, disease progression, key events, the use of ancillary services, and hospitalizations | Other | Patients with Crohn's disease |
Primary outcome
To document the variety of treatment regimens currently employed in the management of Crohn's disease
Time frame: Five years
4 secondary outcomes
To assess clinical, economic, and humanistic outcomes of treatment
Time frame: Five years
To assess the long-term impact of various Crohn's disease treatment regimens
Time frame: Five years
To assess long-term outcomes specifically associated with the use of Remicade
Time frame: Five years
Collection of adverse events
Time frame: Five 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 4 Mar 2013.
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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.
Janssen Biotech, Inc. Clinical Trial study director
Janssen Biotech, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Janssen Biotech, Inc..
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 1 inclusion and 2 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 4 Mar 2013. 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?
To document the variety of treatment regimens currently employed in the management of Crohn's disease (time frame: Five years). 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 4 Mar 2013.