Impact of HLA-DQA1*05 Genotype on Anti-TNF Treatment Monitoring in Adults
Influence of HLA-DQA1*05 Genotype in Adults With Inflammatory Bowel Disease and Anti-TNF Treatment With Proactive Therapeutic Drug Monitoring. A Prospective Multicenter Study.
This study is testing if checking drug levels can help adults with Crohn's disease or ulcerative colitis who carry a specific gene variant stick with their anti-TNF treatments longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital del Rio Hortega Academic / other |
| Drugs / interventions | infliximab, adalimumab |
| Locations | 1 site (Valladolid) |
| Trial ID | NCT05986903 on ClinicalTrials.gov |
What this trial studies
This observational cohort study investigates the influence of the HLA-DQA1*05 genotype on the effectiveness of proactive therapeutic drug monitoring (PTDM) in adults with inflammatory bowel diseases, specifically those treated with anti-TNF therapies like infliximab and adalimumab. The study aims to determine whether PTDM can enhance the persistence of these treatments in patients who are carriers of the HLA-DQA1*05 variant. Eligible participants include adults diagnosed with Crohn's disease or ulcerative colitis who are initiating anti-TNF therapy and are naïve to biological treatments. The study will monitor drug levels during treatment to optimize therapy outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a diagnosis of inflammatory bowel disease who are starting anti-TNF therapy and have not previously received biological treatment.
Not a fit: Patients who are already on combination treatment with immunomodulators or those initiating anti-TNF treatment for extraintestinal manifestations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment persistence and outcomes for patients with inflammatory bowel diseases who carry the HLA-DQA1*05 genotype.
How similar studies have performed: While the specific approach of proactive therapeutic drug monitoring in relation to the HLA-DQA1*05 genotype has not been extensively studied, similar monitoring strategies have shown promise in enhancing treatment outcomes in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of inflammatory bowel disease according to ECCO criteria. * Older than 18 years * Subjects naïve to biological treatment * Anti-TNF treatment initiation (infliximab or adalimumab) due to intestinal activity and/or perianal disease. * Avaibility to evaluate HLA DQA1\*05 status * Proactive therapeutic drug monitoring of anti-TNF levels Exclusion Criteria: * Initiation of anti-TNF treatment as prevention of post-surgical recurrence in Crohn's disease during the first 12 months after surgery or, afterwards, if endoscopic recurrence with a Rutgeerts 0-1. * Initiation of anti-TNF treatment under combo treatment with immunomodulator. Prior initiation of immunomodulator or prior use and suspension would not be a contraindication. * Initiation of anti-TNF treatment due to extraintestinal activity. * Initiation of anti-TNF treatment by a non-gastroenterologist specialist. * Initiation of anti-TNF treatment during pregnancy.
Where this trial is running
Valladolid
- Hospital Universitario Rio Hortega — Valladolid, Spain (Recruiting)
Study contacts
- Study coordinator: Esteban Fuentes-Valenzuela, MD
- Email: estebanfuentes_2@hotmail.co
- Phone: +34 983 42 04 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.