Status unknownNCT02066272SATIMOSUpdated Apr 7, 2015

Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease

An observational study in Inflammatory Bowel Disease, Ulcerative Colitis and Crohn's Disease, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Status unknown at 2 sites in Poland. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Observational

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 400
Sex: All

Study 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. 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.

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.

Conditions studied

Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Indeterminate Colitis

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Keywords

IBD
anti-TNF
biosimilars
safety

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's planned enrollment of 400 is above the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

All IBD patients who start or re-start anti-TNF therapy within the study period.

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

Exclusion Criteria:

Lack of the patient's consent
Participation in a clinical trial with anti - TNFs

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 400 participants (estimated)
Target follow-up: 2 Years
Patient registry: Yes

Groups and cohorts

IBD patients
IBD patients who start or re-start anti-TNF therapy

What researchers measure

Primary outcomes

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

Study locations

2 of 2 sites recruiting

Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology
Warsaw, Mazowieckie 02781, Poland
- Edyta Zagorowicz, MD, PhD · Contact · ezagorowicz@wp.pl
- Edyta Zagorowicz, MD, PhD · Principal investigator
- Marek Bugajski, MD · Sub investigator
- Magdalena Chruscielewska-Kiliszek, MD, PhD · Sub investigator
- Anna Pietrzak, MD · Sub investigator
Recruiting
Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute
Warsaw, Mazowieckie 04730, Poland
- Jaroslaw Kierkus, MD, PhD · Contact · j.kierkus@czd.pl
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02066272
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators: The Children's Memorial Health Institute, Poland, Intestinal Section of the Polish Society of Gastroenterology
Responsible party: Edyta Zagorowicz (MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology) — Principal investigator
First posted: Feb 19, 2014
Start date: Jan 2014
Primary completion: Dec 2015 (estimated)
Completion: Dec 2016 (estimated)
Last update: Apr 7, 2015

Study contacts

Edyta Zagorowicz, MD,PhD

Contact

ezagorowicz@wp.pl

+48225462328

Jaroslaw Kierkus, MD,PhD

Contact

j.kierkus@czd.pl

+48228157384

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

Maria Wisniewska-Jarosinska, MD, PhD

study chair · Gastroenterology and Endoscopy Unit, Medical University of Lodz, St Family Hospital, Lodz, Poland

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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