- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02066272
Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease (SATIMOS)
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.
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.
Přehled studie
Postavení
Detailní popis
- 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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Edyta Zagorowicz, MD,PhD
- Telefonní číslo: +48225462328
- E-mail: ezagorowicz@wp.pl
Studijní záloha kontaktů
- Jméno: Jaroslaw Kierkus, MD,PhD
- Telefonní číslo: +48228157384
- E-mail: j.kierkus@czd.pl
Studijní místa
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Mazowieckie
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Warsaw, Mazowieckie, Polsko, 02781
- Nábor
- Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology
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Kontakt:
- Edyta Zagorowicz, MD, PhD
- E-mail: ezagorowicz@wp.pl
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Vrchní vyšetřovatel:
- Edyta Zagorowicz, MD, PhD
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Dílčí vyšetřovatel:
- Marek Bugajski, MD
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Dílčí vyšetřovatel:
- Magdalena Chruscielewska-Kiliszek, MD, PhD
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Dílčí vyšetřovatel:
- Anna Pietrzak, MD
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Warsaw, Mazowieckie, Polsko, 04730
- Nábor
- Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute
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Kontakt:
- Jaroslaw Kierkus, MD, PhD
- E-mail: j.kierkus@czd.pl
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Lack of the patient's consent
- Participation in a clinical trial with anti - TNFs
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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IBD patients
IBD patients who start or re-start anti-TNF therapy
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
The frequency of adverse events on induction of remission and maintenance treatment using anti-TNFs (including biosimilars) in a cohort of IBD patients
Časové okno: Up to 3 years
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Up to 3 years
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Edyta Zagorowicz, MD, PhD, Department of Gastroenterological Oncology, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland
- Vrchní vyšetřovatel: Jaroslaw Kierkus, MD, PhD, Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw , Poland
- Studijní židle: Maria Klopocka, MD, PhD, Interventional Endoscopy Center, Outpatient Department for Bowel Diseases, University Hospital nr 2 in Bydgoszcz, Poland
- Studijní židle: Maria Wisniewska-Jarosinska, MD, PhD, Gastroenterology and Endoscopy Unit, Medical University of Lodz, St Family Hospital, Lodz, Poland
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 29/2013
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