Personalising Anti-TNF Therapy in Crohns Disease (PANTS)

NCT03088449 | Unknown DMC

• 1 other identifier: RDE 1307805
• Study Type: observational
• Target: 1,750
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

Crohns disease; primary non response; lose of response; personalising anti-TNF therapy; Anti-TNF; PANTS; Biosimilars

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (3)

• To measure the serious adverse events to Anti-TNF in Crohn's disease.

  3 YEARS

• to measure the clinical, biochemical and genetic markers of durable clinical remission after anti-TNF withdrawal

  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.

  2 YEARS

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UK NHS Patients with active luminal Crohn's disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• Merck Sharp & Dohme LLC: collaborator
• AbbVie: collaborator
• Pfizer: collaborator
• Centre for Ocular Research & Education, Canada: collaborator
• Napp Pharmaceuticals Limited: collaborator

Study Sites (1)

Royal Devon and Exeter Hospital NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 38640937 DERIVED

• Bai 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.

  PMID: 37776235 DERIVED

• 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.

  PMID: 31600487 DERIVED

Related Links

• Exeter IBD research website

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, STOOL, SERUM will be collected over the 3 years period from multiple time points.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Tariq Dr Ahmad

  Royal Devon and Exeter Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: March 23, 2017
• Study Start: March 1, 2013
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2019
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)