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.

Study Overview

• Status: Unknown
• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease; Indeterminate Colitis

Detailed Description

1. This is a prospective observational study aimed to register adverse events occuring on biological treatment in inflammatory bowel disease (IBD) patients in Poland.
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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
IBD patients; IBD patients who start or re-start anti-TNF therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The frequency of adverse events on induction of remission and maintenance treatment using anti-TNFs (including biosimilars) in a cohort of IBD patients	Up to 3 years

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Edyta Zagorowicz, MD, PhD, Department of Gastroenterological Oncology, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Principal Investigator: Jaroslaw Kierkus, MD, PhD, Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw , Poland; Study Chair: Maria Klopocka, MD, PhD, Interventional Endoscopy Center, Outpatient Department for Bowel Diseases, University Hospital nr 2 in Bydgoszcz, Poland; Study Chair: Maria Wisniewska-Jarosinska, MD, PhD, Gastroenterology and Endoscopy Unit, Medical University of Lodz, St Family Hospital, Lodz, Poland

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: safety; IBD; anti-TNF; biosimilars
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis
• Other Study ID Numbers: 29/2013