Inflammatory Bowel DiseasesFECPEC MICINCT03248024
An Explanatory Factors Analysis of Inflammatory Bowel Diseases(IBD's) Management Costs for Adults Patients Treated by Biotherapy and Followed at Nancy University Hospital
An observational study of Inflammatory Bowel Diseases, run by Central Hospital, Nancy, France.
Trial summary
The objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2016to 7 Feb 2017
- 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: Patients who received biotherapy during the last 12 months preceeding consultation for treatment of crohn's disease or ulcerative colitis.
Who may be able to join
- Patients consulted at the Gastroenterology services of Nancy University Hospital during the period of inclusion
- Patients over 18 of age the day of consultation
- Patients treated at least one time by biotherapy during the last 12 months preceeding inclusion
- Patients with crohn's disease or ulcerative colitis.
- Patients accepting to respond to the questionnary
Who cannot join
- Age under 18 years , the day of consultation
- Patient that not accept or unable to complete the retrospective questionnary
About this study
Official title: Etude Des Facteurs Explicatifs Des Coûts de la Prise En Charge Des Patients Adultes Atteints d'Une MICI Suivis au CHRU de Nancy et traités Par biothérapie
The objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative colitis
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Chronic Disease, Ulcerative Colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Chronic Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective health care consumption
Desease treatment cost individual level data
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start28 Nov 2016
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- HEVA - Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248024
- Sponsor's protocol ID
- FECPEC MICI
- Acronym
- FECPEC MICI
- Status last verified
- Jul 2017
- First submitted
- 9 Aug 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Des Facteurs Explicatifs Des Coûts de la Prise En Charge Des Patients Adultes Atteints d'Une MICI Suivis au CHRU de Nancy et traités Par biothérapie
- ClinicalTrials.gov ID
- NCT03248024
- Acronym / sponsor ID
- FECPEC MICI / FECPEC MICI
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Chronic Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- HEVA - Lyon
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 14 Aug 2017 (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 objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative colitis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received biotherapy during the last 12 months preceeding consultation for treatment of crohn's disease or ulcerative colitis.
Key inclusion criteria (5 listed)
- Patients consulted at the Gastroenterology services of Nancy University Hospital during the period of inclusion
- Patients over 18 of age the day of consultation
- Patients treated at least one time by biotherapy during the last 12 months preceeding inclusion
- Patients with crohn's disease or ulcerative colitis.
- Patients accepting to respond to the questionnary
Key exclusion criteria (2 listed)
- Age under 18 years , the day of consultation
- Patient that not accept or unable to complete the retrospective questionnary
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
Retrospective health care consumption
Time frame: one year
Desease treatment cost individual level data
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 14 Aug 2017.
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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 Inflammatory Bowel Diseases, run by Central Hospital, Nancy, France.
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 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 14 Aug 2017. 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?
Retrospective health care consumption (time frame: one 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 14 Aug 2017.