Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases

NCT02508012 | Completed

• 1 other identifier: 9535
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

anti-TNF; Immuno-monitoring; Anti-drug antibody (ADAb); Inflammatory bowel disease (IBD); Crohn's disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• cost-utility analysis of the immunomonitoring strategy

  incremental cost-effectiveness ratio

  2 years

Secondary Outcomes (1)

• quality of life

  2 years

Study Arms (2)

Immuno monitoring

EXPERIMENTAL

in case of loss of response, the clinician uses immunomonitoring data to adapt the treatment following a treatment algorithm.

Other: Immuno monitoring

No immuno monitoring

NO INTERVENTION

in case of loss of response, immunomonitoring data are not transmit to the clinician who adapts the treatment with classical biological informations.

Interventions

Immuno monitoring OTHER

treatment optimization

Immuno monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with Crohn's disease or ulcerative colitis
• Treated with anti-TNF

You may not qualify if:

• anti-TNF contraindication
• Previous treatment with anti-TNF

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Department of the medical information of Montpellier: collaborator

Study Sites (1)

University hospital

Montpellier, 34295, France

Location

Related Publications (15)

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  PMID: 20157022 BACKGROUND

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• Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013 Jan;108(1):40-7; quiz 48. doi: 10.1038/ajg.2012.363. Epub 2012 Nov 13.

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  PMID: 23419382 BACKGROUND

• Steenholdt C, Svenson M, Bendtzen K, Thomsen OO, Brynskov J, Ainsworth MA. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Jul;34(1):51-8. doi: 10.1111/j.1365-2036.2011.04682.x. Epub 2011 May 3.

  PMID: 21535447 BACKGROUND

• Afif W, Loftus EV Jr, Faubion WA, Kane SV, Bruining DH, Hanson KA, Sandborn WJ. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May;105(5):1133-9. doi: 10.1038/ajg.2010.9. Epub 2010 Feb 9.

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• Steenholdt C, Brynskov J, Thomsen OO, Munck LK, Fallingborg J, Christensen LA, Pedersen G, Kjeldsen J, Jacobsen BA, Oxholm AS, Kjellberg J, Bendtzen K, Ainsworth MA. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut. 2014 Jun;63(6):919-27. doi: 10.1136/gutjnl-2013-305279. Epub 2013 Jul 22.

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• Paul S, Del Tedesco E, Marotte H, Rinaudo-Gaujous M, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2013 Nov;19(12):2568-76. doi: 10.1097/MIB.0b013e3182a77b41.

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  PMID: 23891927 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Thierry VINCENT, MD, PhD

  Department of immunology in Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 24, 2015
• Study Start: September 24, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (1)