Influence of HLA-DQA1*05 Genotype in Adults With Anti-TNF Treatment With

Status Recruiting

Clinical Trial Summary

HLA-DQA1*05 variant carriers are at risk of developing antibodies against infliximab and adalimumab with reduced TNF antagonist persistence. The impact of proactive therapeutic drug monitoring (PTDM) on this association has been barely assessed. Therefor, we propose a cohort study including adult patients with Crohn's disease and ulcerative colitis treated with TNF antagonists under proactive therapeutic drug monitoring. Our hypothesis is that, proactive therapeutic drug monitoring could be an alternative to combination treatment with immunomodulators to increase TNF-antagonists' persistence in HLA-DQA1*05 carriers.

Clinical Trial Description

Population study: patients with inflammatory bowel disease and initiation of anti-TNF therapy Inclusion and exclusion criteria The inclusion criteria are: - Patient diagnosed with inflammatory bowel disease based on clinical, endoscopic, and pathological criteria according to ECCO criteria. - Initiation of anti-TNf, including infliximab and adalimumab. - Subjects naïve to biological treatment - Age >18 years. The exclusion criteria are: - No determination of HLA DQA1*5 allele. - No proactive drug monitoring - Initiation of anti-TNF treatment as prevention of post-surgical recurrence in Crohn's disease during the first 12 months after surgery or, after that time, with a colonoscopy with a Rutgeerts 0-1 - Anti-TNF treatment with combined treatment with immunomodulator. Prior initiation of immunomodulator or prior use and suspension would not be a contraindication - Initiation of anti-TNF treatment for extraintestinal manifestation - Initiation of anti-TNF treatment during pregnancy. Proactive drug monitoring was defined as standardized determination of drug levels during induction and maintenance, with optimization independently of the patient's clinical status, until reaching target levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05986903
Study type	Observational
Source	Hospital del Río Hortega
Contact	Esteban Fuentes-Valenzuela, MD
Phone	+34 983 42 04 00
Email	estebanfuentes_2@hotmail.co
Status	Recruiting
Phase
Start date	January 11, 2023
Completion date	January 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Influence of HLA-DQA1*05 Genotype in Adults With Anti-TNF Treatment With Proactive Therapeutic Drug Monitoring. — Proa-DQ

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms