Join the PANTS Study!
Inclusion of patients receiving Biosimilar Infliximab - Remsima™ & Inflectra™
Dr Tariq Ahmad
The latest version of the PANTS protocol allows the inclusion of Crohn's disease patients receiving Biosimilar Infliximab. Specifically this allows
- Inclusion of anti-TNF naive Crohn's disease patients starting Remsima™ or Inflectra™
- Existing PANTS study participants receiving RemicadeTM to switch to Remsima™ or Inflectra™
The PANTS study is a prospective uncontrolled cohort study investigating primary non-response, loss of response and adverse drug reactions to Infliximab and Adalimumab in patients with severe active luminal Crohn's disease. The study started in March 2013 and to date 1200 patients aged over 6 years have been recruited from 118 UK hospitals. The collection of clinical data is aligned and shared with the Royal College of Physicians UK IBD Biologics Audit (and in due course with the UK IBD registry), and individual patient laboratory data is released on the web portal.
Biosimilar Infliximab became available in the UK in February 2015 offering significant savings to the National Health Service. Extensive non-clinical and clinical data have shown comparability with the reference product, Remicade™. However the clinical data to date has emerged from the use of Biosimilar Infliximab in studies of patients with Ankylosing Spondylitis and Rheumatoid Arthritis. The PANTS study will report the initial UK experience of Biosimilar Infliximab in Crohn's disease, providing important post-authorisation data on efficacy (at week 14, 30 and 54), safety (to 3 years) and pharmacokinetics. We aim to include 225 patients treated with Biosimilar Infliximab as first-line anti-TNF treatment and 100 PANTS "switchers" over the next 12 months. Please do consider recruiting your patients to the PANTS study.
Paediatric European Digestive Diseases Clinical Research Network – PEDDCReN
PEDDCReN was an exciting new initiative with the key aim of forming a clinical trials network to study (and ultimately provide) effective medicines for paediatric patients in the speciality of Gastroenterology, Hepatology and Nutrition. It was established with the support of LINK funding from the UEG and was led by the BSG in collaboration with various European societies and ENPR-EMA (The European Network of Paediatric Research at the European Medicines Agency). The project supported both industry and non-industry investigators in running high quality multi-centre clinical trials. The final report has now been published.
- Further information [ 780 kb ]
HCV clinical trial and tissue biobank
HCV Research UK is a national cohort of over 11,000 patients enrolled between 2012 and 2014 from 60 centres within the UK with evidence of hepatitis C virus infection. All patients have enrolled with written informed consent, which allows storage of routinely collected clinical data in a linked-anonymised database, and have donated biological samples to a biorepository (held in Glasgow).
The purpose of HCV Research UK is to act as a resource to support research into a range of aspects of HCV infection.
Applications for access to data and/or samples may be made through the HCV Research UK Tissue and Data Access Committee through completion of an on-line application form.
Further details may be found at www.hcvresearchuk.org
ENDCaP-C Study: Enhanced Neoplasia Detection and Cancer Prevention in Chronic Colitis
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