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

NCT02066272 | Unknown DMC

• 1 other identifier: 29/2013
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease; Indeterminate Colitis

Keywords

IBD; anti-TNF; biosimilars; safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IBD patients

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• The Children's Memorial Health Institute, Poland: collaborator
• Intestinal Section of the Polish Society of Gastroenterology: collaborator

Study Sites (2)

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, Poland

RECRUITING

Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute

Warsaw, Masovian Voivodeship, 04730, Poland

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

Edyta Zagorowicz, MD,PhD

CONTACT

+48225462328; ezagorowicz@wp.pl

Jaroslaw Kierkus, MD,PhD

CONTACT

+48228157384; j.kierkus@czd.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 19, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

PL (2)