Inflammatory Bowel DiseaseSATIMOSNCT02066272
Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease and Ulcerative Colitis, run by Maria Sklodowska-Curie National Research Institute of Oncology at 2 sites in Poland.
Trial summary
Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of Inflammatory bowel disease. Their common features include high efficacy but also immunogenicity and increased infection risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
- How many people
- 400 participants
- Where
- 2 sitesPoland
- Study dates
- Jan 2014to Dec 2016
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All IBD patients who start or re-start anti-TNF therapy within the study period.
Who may be able to join
- All consecutive patients with pre-diagnosed ulcerative colitis, Crohn's disease or undeterminate colitis who start or re-start anti-TNF treatment in a study centre
- Gave their consent to participate in the study (in children, caretakers consent is required)
Who cannot join
- Lack of the patient's consent
- Participation in a clinical trial with anti - TNFs
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology
Warsaw, Masovian Voivodeship, 02781
Edyta Zagorowicz, MD, PhD, ezagorowicz@wp.pl
Edyta Zagorowicz, MD, PhD
- Recruiting
Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute
Warsaw, Masovian Voivodeship, 04730
Jaroslaw Kierkus, MD, PhD, j.kierkus@czd.pl
About this study
Official title: Safety of Anti-TNF Antibodies, Including Biosimilars, in Treatment of Inflammatory Bowel Disease: Multicentre Cohort Observational Study (SATIMOS)
Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of Inflammatory bowel disease. Their common features include high efficacy but also immunogenicity and increased infection risk. Since 2013, two generics or biosimilars of the first anti-TNF have been registered in Europe, which long lerm safety profile needs yet to be established.
This prospective, multicenter, observational cohort study will assess safety of treatment of anti-TNF monoclonal antibodies in inflammatory bowel disease patients in Poland.
Read more
Eligible are consecutive patients in whom anti-TNF is started for Crohn's disease, ulcerative colitis or indeterminate colitis between January 1st, 2014 and December 31st, 2015. Data to be collected include demography, Montreal classification, indication to treatment, previous treatment, operations, extraintestinal manifestations and concomitant diseases. Data on response, tolerability and safety of anti-TNF and on concomitant treatment will be collected. Adverse events logs will be completed. Majority of IBD centres in Poland, pediatric and adult, academic and regional, have agreed to participate in the study.
As a result of the study, the frequency of adverse events in a cohort of Polish IBD patients on various anti-TNFs will be established.
Read the detailed description
- This is a prospective observational study aimed to register adverse events occuring on biological treatment in inflammatory bowel disease (IBD) patients in Poland.
- Eligible are pediatric and adult patients in whom anti-TNF (tumor necrosis factor) treatment is started for Crohn's disease, ulcerative colitis or indeterminate colitis, financed by the National Health Care System and who gave their informed consent for participation in the study (for children the consent of a parent is required).
- The study data are collected in a dedicated on-line data - base.
- Each centre participating in the study is obliged to screen for the study all consecutive patients in whom the biological treatment is started. If a patient refuses to consent, this information must have been documented in the data - base.
- Patient data collected at the start of anti-TNF treatment include the type of anti-TNF, demographic data, the type, extension or location, course and activity of IBD, indication to biological treatment, history of previous treatment, operations, extraintestinal manifestations and co-existing diseases. As regards to the anti-TNFs, biosimilars are categorised as distinct drugs in order to separately follow-up the safety profile of each.
- Data on response, tolerability and safety of anti-TNF and on concomitant treatment are updated following each visit. Adverse events logs and serious adverse events log are completed if necessary.
- Registration of new patients will be ongoing from Jan 2014 do Dec 2015. After this time, a centre may choose to continue doing the study.
- In addition, data on health events in enrolled patients will be collected independently from the National Health Care System database, also after the on-site observation of patients is completed.
- Keywords
- IBD, anti-TNF, biosimilars, safety
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, 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 |
|---|---|---|
| IBD patients | IBD patients who start or re-start anti-TNF therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of adverse events on induction of remission and maintenance treatment using anti-TNFs (including biosimilars) in a cohort of IBD patients
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Memorial Health Institute, Poland, Intestinal Section of the Polish Society of Gastroenterology
- Responsible party
- Principal investigator, Edyta Zagorowicz, Maria Sklodowska-Curie National Research Institute of Oncology
- Investigators
- Edyta Zagorowicz, MD, PhD, Principal investigator, Department of Gastroenterological Oncology, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, PolandJaroslaw Kierkus, MD, PhD, Principal investigator, Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw , PolandMaria Klopocka, MD, PhD, Study chair, Interventional Endoscopy Center, Outpatient Department for Bowel Diseases, University Hospital nr 2 in Bydgoszcz, PolandMaria Wisniewska-Jarosinska, MD, PhD, Study chair, Gastroenterology and Endoscopy Unit, Medical University of Lodz, St Family Hospital, Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066272
- Sponsor's protocol ID
- 29/2013
- Acronym
- SATIMOS
- Status last verified
- Apr 2015
- First submitted
- 13 Feb 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Anti-TNF Antibodies, Including Biosimilars, in Treatment of Inflammatory Bowel Disease: Multicentre Cohort Observational Study (SATIMOS)
- ClinicalTrials.gov ID
- NCT02066272
- Acronym / sponsor ID
- SATIMOS / 29/2013
- Keywords
- IBD, anti-TNF, biosimilars, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Children's Memorial Health Institute, Poland, Intestinal Section of the Polish Society of Gastroenterology
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Feb 2014 (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.
Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of Inflammatory bowel disease. Their common features include high efficacy but also immunogenicity and increased infection risk. Since 2013, two generics or biosimilars of the first anti-TNF have been registered in Europe, which long lerm safety profile needs yet to be established.
This prospective, multicenter, observational cohort study will assess safety of treatment of anti-TNF monoclonal antibodies in inflammatory bowel disease patients in Poland.
Eligible are consecutive patients in whom anti-TNF is started for Crohn's disease, ulcerative colitis or indeterminate colitis between January 1st, 2014 and December 31st, 2015. Data to be collected include demography, Montreal classification, indication to treatment, previous treatment, operations, extraintestinal manifestations and concomitant diseases. Data on response, tolerability and safety of anti-TNF and on concomitant treatment will be collected. Adverse events logs will be completed. Majority of IBD centres in Poland, pediatric and adult, academic and regional, have agreed to participate in the study.
As a result of the study, the frequency of adverse events in a cohort of Polish IBD patients on various anti-TNFs will be established.
Detailed description
- This is a prospective observational study aimed to register adverse events occuring on biological treatment in inflammatory bowel disease (IBD) patients in Poland.
- Eligible are pediatric and adult patients in whom anti-TNF (tumor necrosis factor) treatment is started for Crohn's disease, ulcerative colitis or indeterminate colitis, financed by the National Health Care System and who gave their informed consent for participation in the study (for children the consent of a parent is required).
- The study data are collected in a dedicated on-line data - base.
- Each centre participating in the study is obliged to screen for the study all consecutive patients in whom the biological treatment is started. If a patient refuses to consent, this information must have been documented in the data - base.
- Patient data collected at the start of anti-TNF treatment include the type of anti-TNF, demographic data, the type, extension or location, course and activity of IBD, indication to biological treatment, history of previous treatment, operations, extraintestinal manifestations and co-existing diseases. As regards to the anti-TNFs, biosimilars are categorised as distinct drugs in order to separately follow-up the safety profile of each.
- Data on response, tolerability and safety of anti-TNF and on concomitant treatment are updated following each visit. Adverse events logs and serious adverse events log are completed if necessary.
- Registration of new patients will be ongoing from Jan 2014 do Dec 2015. After this time, a centre may choose to continue doing the study.
- In addition, data on health events in enrolled patients will be collected independently from the National Health Care System database, also after the on-site observation of patients is completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | –IBD patients who start or re-start anti-TNF therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All IBD patients who start or re-start anti-TNF therapy within the study period.
Key inclusion criteria (2 listed)
- All consecutive patients with pre-diagnosed ulcerative colitis, Crohn's disease or undeterminate colitis who start or re-start anti-TNF treatment in a study centre
- Gave their consent to participate in the study (in children, caretakers consent is required)
Key exclusion criteria (2 listed)
- Lack of the patient's consent
- Participation in a clinical trial with anti - TNFs
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
The frequency of adverse events on induction of remission and maintenance treatment using anti-TNFs (including biosimilars) in a cohort of IBD patients
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Edyta Zagorowicz, MD, PhD principal investigator
Department of Gastroenterological Oncology, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland
Jaroslaw Kierkus, MD, PhD principal investigator
Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw , Poland
Maria Klopocka, MD, PhD study chair
Interventional Endoscopy Center, Outpatient Department for Bowel Diseases, University Hospital nr 2 in Bydgoszcz, Poland
2 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 Disease and Ulcerative Colitis, run by Maria Sklodowska-Curie National Research Institute of Oncology at 2 sites in Poland.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edyta Zagorowicz, MD,PhD (+48225462328, ezagorowicz@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of adverse events on induction of remission and maintenance treatment using anti-TNFs (including biosimilars) in a cohort of IBD patients (time frame: Up to 3 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 7 Apr 2015.