Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease
NCT ID: NCT02066272
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2014-01-31
2016-12-31
Brief Summary
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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.
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Detailed Description
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2. 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).
3. The study data are collected in a dedicated on-line data - base.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IBD patients
IBD patients who start or re-start anti-TNF therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Gave their consent to participate in the study (in children, caretakers consent is required)
Exclusion Criteria
* Participation in a clinical trial with anti - TNFs
ALL
No
Sponsors
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The Children's Memorial Health Institute, Poland
UNKNOWN
Intestinal Section of the Polish Society of Gastroenterology
UNKNOWN
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Edyta Zagorowicz
MD, PhD
Principal Investigators
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Edyta Zagorowicz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterological Oncology, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland
Jaroslaw Kierkus, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw , Poland
Maria Klopocka, MD, PhD
Role: STUDY_CHAIR
Interventional Endoscopy Center, Outpatient Department for Bowel Diseases, University Hospital nr 2 in Bydgoszcz, Poland
Maria Wisniewska-Jarosinska, MD, PhD
Role: STUDY_CHAIR
Gastroenterology and Endoscopy Unit, Medical University of Lodz, St Family Hospital, Lodz, Poland
Locations
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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, Poland
Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29/2013
Identifier Type: -
Identifier Source: org_study_id
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