Crohn DiseasePANTSNCT03088449
Personalising Anti-TNF Therapy in Crohns Disease (PANTS)
An observational study of Crohn Disease, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Crohn Disease
- How many people
- 1,750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: UK NHS Patients with active luminal Crohn's disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon and Exeter Hospital NHS Foundation Trust
Exeter, EX2 5DW
About this study
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
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.
Read the 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.
- Conditions
- Crohn Disease
- Keywords
- Crohns disease, primary non response, lose of response, personalising anti-TNF therapy, Anti-TNF, PANTS, Biosimilars
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the clinical, biological, genetic markers that define response to anti-TNF in patients with active Crohns disease
We will measure biomarkers, clinical data and genetic data through the PANTS project at multi time points.
Measured: 3 years
Secondary outcomes (3)
To measure the serious adverse events to Anti-TNF in Crohn's disease.
Measured: 3 YEARS
to measure the clinical, biochemical and genetic markers of durable clinical remission after anti-TNF withdrawal
Measured: 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.
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study startMar 2013
- Primary completion30 Jul 2017
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, AbbVie, Pfizer, Centre for Ocular Research & Education, Canada, Napp Pharmaceuticals Limited
- Responsible party
- Sponsor
- Investigators
- Tariq Dr Ahmad, Principal investigator, Royal Devon and Exeter Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088449
- Sponsor's protocol ID
- RDE 1307805
- Acronym
- PANTS
- Status last verified
- Jun 2018
- First submitted
- 6 Jan 2014
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical and genetic data will be entered into the Peninsular Resreach Bank or another Biobank for sharing
Publications
Chanchlani N, Lin S, Bewshea C, Hamilton B, Thomas A, Smith R, Roberts C, Bishara M, Nice R, Lees CW, Sebastian S, Irving PM, Russell RK, McDonald TJ, Goodhand JR, Ahmad T, Kennedy NA; PANTS Consortium. Mechanisms and management of loss of response to anti-TNF therapy for patients with Crohn's disease: 3-year data from the prospective, multicentre PANTS cohort study. Lancet Gastroenterol Hepatol. 2024 Jun;9(6):521-538. doi: 10.1016/S2468-1253(24)00044-X. Epub 2024 Apr 16.
PubMed 38640937Bai BYH, Reppell M, Smaoui N, Waring JF, Pivorunas V, Guay H, Lin S, Chanchlani N, Bewshea C, Goodhand JR, Kennedy NA, Ahmad T, Anderson CA; UK Inflammatory Bowel Disease Pharmacogenetics Study Group. Baseline Expression of Immune Gene Modules in Blood is Associated With Primary Response to Anti-TNF Therapy in Crohn's Disease Patients. J Crohns Colitis. 2024 Mar 1;18(3):431-445. doi: 10.1093/ecco-jcc/jjad166.
PubMed 37776235Sazonovs 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.
PubMed 31600487
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03088449
- Acronym / sponsor ID
- PANTS / RDE 1307805
- Conditions
- Crohn Disease
- Keywords
- Crohns disease, primary non response, lose of response, personalising anti-TNF therapy, Anti-TNF, PANTS, Biosimilars
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,750 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, AbbVie, Pfizer, Centre for Ocular Research & Education, Canada, Napp Pharmaceuticals Limited
- Study start
- Mar 2013
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- UK NHS Patients with active luminal Crohn's disease.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Derived from this study: PubMed 38640937Chanchlani N, Lin S, Bewshea C, Hamilton B, Thomas A, Smith R, Roberts C, Bishara M, Nice R, Lees CW, Sebastian S, Irving PM, Russell RK, McDonald TJ, Goodhand JR, Ahmad T, Kennedy NA; PANTS Consortium. Mechanisms and management of loss of response to anti-TNF therapy for patients with Crohn's disease: 3-year data from the prospective, multicentre PANTS cohort study. Lancet Gastroenterol Hepatol. 2024 Jun;9(6):521-538. doi: 10.1016/S2468-1253(24)00044-X. Epub 2024 Apr 16.
- Derived from this study: PubMed 37776235Bai BYH, Reppell M, Smaoui N, Waring JF, Pivorunas V, Guay H, Lin S, Chanchlani N, Bewshea C, Goodhand JR, Kennedy NA, Ahmad T, Anderson CA; UK Inflammatory Bowel Disease Pharmacogenetics Study Group. Baseline Expression of Immune Gene Modules in Blood is Associated With Primary Response to Anti-TNF Therapy in Crohn's Disease Patients. J Crohns Colitis. 2024 Mar 1;18(3):431-445. doi: 10.1093/ecco-jcc/jjad166.
- Derived from this study: PubMed 31600487Sazonovs 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.
- Exeter IBD research websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The clinical and genetic data will be entered into the Peninsular Resreach Bank or another Biobank for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tariq Dr Ahmad principal investigator
Royal Devon and Exeter Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the clinical, biological, genetic markers that define response to anti-TNF in patients with active Crohns disease (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088449, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.