Personalising Anti-TNF Therapy in Crohns Disease (PANTS) (PANTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03088449|
Recruitment Status : Unknown
Verified June 2018 by Royal Devon and Exeter NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : June 21, 2018
To develop a cost-effective, individualised anti-TNF treatment strategy for patients with Crohn's disease which maximizes benefit and minimises harm.
The primary objective of this study is to investigate the mechanisms that underlie primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADRs) to anti-TNF drugs in patients with active luminal Crohn's disease.
|Condition or disease|
This is a prospective uncontrolled cohort study investigating primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADR) to IFX and ADA in patients with severe active luminal Crohn's disease. The primary objective of this study is to investigate the mechanisms that underlie PNR, LOR, ADRs and remission after anti-TNF withdrawal. The secondary aims are to develop personalised anti-TNF treatment strategies, through the identification of clinically meaningful serological and genetic predictive markers.
This study builds on the achievements of the UK and international IBDGC in identifying IBD susceptibility genes. These discoveries have provided important insights into disease pathogenesis but are not expected to have an impact in the clinic for a number of years. This study aims to take genetics and biomarker discovery into the IBD clinic to address questions of immediate clinical importance.
The study will commence in February 2013 utilising the network of 120 UK hospitals currently participating in the UK IBDGC pharmacogenetic programme (www.ibdresearch.co.uk). The collection of clinical data is aligned with the data being collected by the Royal College of Physicians UK IBD Biologics Audit. The clinical data for PANTS will be collected separately using a dedicated application held within the N3 network (www.pantsdb.co.uk). In order to avoid duplicate data entry we will share relevant anonymised data with the UK IBD Biologics Audit (and in due course with the UK IBD registry). The PANTS study aims to build a bio-resource for use by the UK IBD scientific community. Anonymised data will be made available to interested parties following appropriate ethical approval and consideration by the scientific management committee.
Patients will not be randomly allocated to one therapy or another and no attempt will be made to match populations including control for disease activity. Therefore the study has not been designed to directly compare PNR or LOR rates between IFX and ADA.
This observational study is funded by CORE, the British Society of Gastroenterology research charity and by unrestricted educational grants from Merck Sharp & Dohme (MSD) and AbbVie. The sponsor of the study is the Royal Devon and Exeter NHS Foundation Trust.
|Study Type :||Observational|
|Actual Enrollment :||1750 participants|
|Official Title:||Investigation of the Clinical,Serological and Genetic Factors That Determine Primary Non-response, Loss of Response and Adverse Drug Reactions to Anti-TNF Drugs in Patients With Active Luminal Crohn's Disease|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 30, 2017|
|Estimated Study Completion Date :||July 30, 2019|
- To measure the clinical, biological, genetic markers that define response to anti-TNF in patients with active Crohns disease [ Time Frame: 3 years ]We will measure biomarkers, clinical data and genetic data through the PANTS project at multi time points.
- To measure the serious adverse events to Anti-TNF in Crohn's disease. [ Time Frame: 3 YEARS ]
- to measure the clinical, biochemical and genetic markers of durable clinical remission after anti-TNF withdrawal [ Time Frame: 3 YEARS ]
- To measure the clinical, biological and genetics marker for patients recruited and switched to biosimilar Infliximab (RemsimaTM and InflectraTM) including efficacy, safety and pharmacokinetics using a prospective open labelled study design. [ Time Frame: 2 YEARS ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088449
|Royal Devon and Exeter Hospital NHS Foundation Trust|
|Exeter, United Kingdom, EX2 5DW|
|Principal Investigator:||Tariq Dr Ahmad||Royal Devon and Exeter Hospital NHS Trust|