Inflammatory Bowel DiseasesPREMONITION-CDNCT03668249
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Takeda at 8 sites in Spain.
Trial summary
The descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease
- How many people
- 5,938 participants
- Where
- 8 sitesSpain
- Study dates
- 26 Sep 2018to 16 Sep 2019
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants diagnosed with CD, will be observed retrospectively.
Who may be able to join
- 1. Diagnosed with CD from the medical centers participating in the study.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
HM Hospitales
Boadilla, Madrid, 28660
H. U. de Fuenlabrada
Fuenlabrada, Madrid, 28942
H La Princesa
Madrid, 28006
H.U. Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222
H.U. Rey Juan Carlos
Móstoles, Madrid, 28933
H.U. Infanta Sofia
San Sebastián de los Reyes, Madrid, 28703
H. U. Infanta Elena
Valdemoro, Madrid, 28342
H Infanta Leonor y Virgen de la Torre
Vallecas, Madrid, 28031
About this study
Official title: Characterization of a Multidimensional Model to Predict the Course of Crohn's Disease: A Pilot Study
The descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. The clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. The predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the Autonomous Community of Madrid, capable of assigning any participant diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.
Read the detailed description
This is a retrospective and non-interventional study of participants with CD. The study will collect data from electronic medical records (EMRs) of the participants in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of EMRs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with CD. This study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site.
The study will have a retrospective data collection from EMRs of the participants referring to last 5 years.
The study will enroll approximately 3000 participants. All participants will be enrolled in one observational cohort.
This multi-center trial will be conducted in Spain. The overall time for data collection in the study will be approximately 5 years.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Keywords
- Drug therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants diagnosed with CD from approximately 12 to 15 investigational sites will be observed retrospectively for previous 5 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who had Relapses
Measured: Approximately 5 years
Number of Participants who had Disease Related Complications
Measured: Approximately 5 years
Number of day Hospital Visits
Measured: Approximately 5 years
Number of Participants who had Surgeries
Measured: Approximately 5 years
Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas
Measured: approximately 5 years
Participant Flow
Measured: Approximately 5 years
Number of Participants who Visit to Other Specialists
Measured: Approximately 5 years
Secondary outcomes (4)
Prevalence of the Different Phenotypes
Development of a statistical predictive model capable of assigning any patient diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.
Measured: Approximately 5 years
Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD
Measured: Approximately 5 years
Number of Direct and Indirect Resources Used
Health care resources of participants with CD will be assessed in terms of direct and indirect resources. Direct resources will include number of hospital admissions, emergency and hospital visits, and tests performed, etc. Indirect resources related to decreased productivity of CD participants through a specific variable, the total number of work days lost due to CD during the study period.
Measured: Approximately 5 years
Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start26 Sep 2018
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- 5,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668249
- Sponsor's protocol ID
- IBD-5002
- Other IDs
- U1111-1220-0873
- Acronym
- PREMONITION-CD
- Status last verified
- Oct 2019
- First submitted
- 11 Sep 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Publications
Gomollon F, Gisbert JP, Guerra I, Plaza R, Pajares Villarroya R, Moreno Almazan L, Lopez Martin MC, Dominguez Antonaya M, Vera Mendoza MI, Aparicio J, Martinez V, Tagarro I, Fernandez-Nistal A, Lumbreras S, Mate C, Montoto C; Premonition-CD Study Group. Clinical characteristics and prognostic factors for Crohn's disease relapses using natural language processing and machine learning: a pilot study. Eur J Gastroenterol Hepatol. 2022 Apr 1;34(4):389-397. doi: 10.1097/MEG.0000000000002317.
PubMed 34882644
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of a Multidimensional Model to Predict the Course of Crohn's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT03668249
- Acronym / sponsor ID
- PREMONITION-CD / IBD-5002
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,938 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- 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 descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. The clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. The predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the Autonomous Community of Madrid, capable of assigning any participant diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.
Detailed description
This is a retrospective and non-interventional study of participants with CD. The study will collect data from electronic medical records (EMRs) of the participants in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of EMRs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with CD. This study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site.
The study will have a retrospective data collection from EMRs of the participants referring to last 5 years.
The study will enroll approximately 3000 participants. All participants will be enrolled in one observational cohort.
This multi-center trial will be conducted in Spain. The overall time for data collection in the study will be approximately 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –Participants diagnosed with CD from approximately 12 to 15 investigational sites will be observed retrospectively for previous 5 years. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants diagnosed with CD, will be observed retrospectively.
Key inclusion criteria (1 listed)
- 1. Diagnosed with CD from the medical centers participating in the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants who had Relapses
Time frame: Approximately 5 years
Number of Participants who had Disease Related Complications
Time frame: Approximately 5 years
Number of day Hospital Visits
Time frame: Approximately 5 years
Number of Participants who had Surgeries
Time frame: Approximately 5 years
Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas
Time frame: approximately 5 years
Participant Flow
Time frame: Approximately 5 years
Number of Participants who Visit to Other Specialists
Time frame: Approximately 5 years
4 secondary outcomes
Prevalence of the Different Phenotypes
Time frame: Approximately 5 years
Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD
Time frame: Approximately 5 years
Number of Direct and Indirect Resources Used
Time frame: Approximately 5 years
Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based
Time frame: Approximately 5 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 3 Oct 2019.
- Derived from this study: PubMed 34882644Gomollon F, Gisbert JP, Guerra I, Plaza R, Pajares Villarroya R, Moreno Almazan L, Lopez Martin MC, Dominguez Antonaya M, Vera Mendoza MI, Aparicio J, Martinez V, Tagarro I, Fernandez-Nistal A, Lumbreras S, Mate C, Montoto C; Premonition-CD Study Group. Clinical characteristics and prognostic factors for Crohn's disease relapses using natural language processing and machine learning: a pilot study. Eur J Gastroenterol Hepatol. 2022 Apr 1;34(4):389-397. doi: 10.1097/MEG.0000000000002317.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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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.
Medical Director study director
Takeda
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Takeda at 8 sites in Spain.
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 0 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 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of Participants who had Relapses (time frame: Approximately 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668249, which also lists 1 linked publication.
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 3 Oct 2019.