Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT05986903
Brief 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.
Detailed 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:
NCT05986903
Study Brief:
Protocol Section:
NCT05986903