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Trial record 1 of 1 for:    NCT03088449
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Personalising Anti-TNF Therapy in Crohns Disease (PANTS) (PANTS)

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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
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
AbbVie
Pfizer
CORE
Napp Pharmaceuticals Limited
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Tracking Information
First Submitted Date January 6, 2014
First Posted Date March 23, 2017
Last Update Posted Date June 21, 2018
Study Start Date March 2013
Actual Primary Completion Date July 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2017)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Personalising Anti-TNF Therapy in Crohns Disease (PANTS)
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
Brief Summary

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.

Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, RNA, STOOL, SERUM will be collected over the 3 years period from multiple time points.
Sampling Method Non-Probability Sample
Study Population UK NHS Patients with active luminal Crohn's disease.
Condition Crohn Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Sazonovs A, Kennedy NA, Moutsianas L, Heap GA, Rice DL, Reppell M, Bewshea CM, Chanchlani N, Walker GJ, Perry MH, McDonald TJ, Lees CW, Cummings JRF, Parkes M, Mansfield JC, Irving PM, Barrett JC, McGovern D, Goodhand JR, Anderson CA, Ahmad T; PANTS Consortium. HLA-DQA1*05 Carriage Associated With Development of Anti-Drug Antibodies to Infliximab and Adalimumab in Patients With Crohn's Disease. Gastroenterology. 2020 Jan;158(1):189-199. doi: 10.1053/j.gastro.2019.09.041. Epub 2019 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: March 16, 2017)
1750
Original Actual Enrollment Same as current
Estimated Study Completion Date July 30, 2019
Actual Primary Completion Date July 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged 6 years and over
  • Patients with active luminal Crohn's disease involving the colon and/or small intestine (Montreal classification L1, L2 or L3), where the primary indication for anti-TNF treatment is NOT fistulising disease.
  • Evidence of active disease supported by raised CRP and/or faecal Calprotectin.
  • No prior exposure to anti-TNF medication.

Exclusion Criteria:

  • Patient unwilling to take part.
  • Unable to obtain written informed consent.
  • Normal CRP and calprotectin at pre-screening.
  • Patient is, in the opinion of the investigator, not suitable to participate in the study.
  • Patients with contraindications to the use of anti-TNF drugs.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03088449
Other Study ID Numbers RDE 1307805
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: The clinical and genetic data will be entered into the Peninsular Resreach Bank or another Biobank for sharing
Responsible Party Royal Devon and Exeter NHS Foundation Trust
Study Sponsor Royal Devon and Exeter NHS Foundation Trust
Collaborators
  • Merck Sharp & Dohme Corp.
  • AbbVie
  • Pfizer
  • CORE
  • Napp Pharmaceuticals Limited
Investigators
Principal Investigator: Tariq Dr Ahmad Royal Devon and Exeter Hospital NHS Trust
PRS Account Royal Devon and Exeter NHS Foundation Trust
Verification Date June 2018