Status:
UNKNOWN
Influence of HLA-DQA1*05 Genotype in Adults With Anti-TNF Treatment With Proactive Therapeutic Drug Monitoring.
Lead Sponsor:
Hospital del Rio Hortega
Collaborating Sponsors:
Francisco Javier Garcia Alonso
Jesús Barrio
Conditions:
Drug Monitoring
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
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...
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 bowe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05986903
Start Date
January 11 2023
End Date
January 1 2025
Last Update
August 14 2023
Active Locations (1)
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1
Hospital Universitario Rio Hortega
Valladolid, Spain