Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : 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

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.


Condition or disease
Crohn 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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 1750 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To measure the serious adverse events to Anti-TNF in Crohn's disease. [ Time Frame: 3 YEARS ]
  2. to measure the clinical, biochemical and genetic markers of durable clinical remission after anti-TNF withdrawal [ Time Frame: 3 YEARS ]
  3. 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
DNA, RNA, STOOL, SERUM will be collected over the 3 years period from multiple time points.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UK NHS Patients with active luminal Crohn's disease.
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United Kingdom
Royal Devon and Exeter Hospital NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Merck Sharp & Dohme Corp.
AbbVie
Pfizer
CORE
Napp Pharmaceuticals Limited
Investigators
Layout table for investigator information
Principal Investigator: Tariq Dr Ahmad Royal Devon and Exeter Hospital NHS Trust

Additional Information:
Layout table for additonal information
Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03088449     History of Changes
Other Study ID Numbers: RDE 1307805
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Crohns disease
primary non response
lose of response
personalising anti-TNF therapy
Anti-TNF
PANTS
Biosimilars
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases