NCT05813860
HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease
Not Yet Recruiting · Phase 4 · Sixth Affiliated Hospital, Sun Yat-sen University · registry updated 2023-05-09
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Crohn's disease (CD) is a chronic non-specific inflammatory disease of the intestine. Infliximab (IFX) is a kind of one of the anti-tumor necrosis factor agents (anti-TNF) and is the main clinical treatment drug for Crohn's disease, but approximately 30-50% of patients develop a secondary non-response to respond within one year. The main cause of secondary non-response failure is the formation of anti-IFX anti-drug antibodies (ADA). The human leukocyte antigen (HLA) gene is a complex allele that has been associated with susceptibility to a variety of diseases. Studies have shown that HLADQA1\*05 allele carriage significantly increases the immunogenicity of anti-tumor necrosis factor agents (anti-TNF) and the risk of ADA formation, resulting in a significant reduction in the efficacy of IFX. Our previous retrospective study found an increased risk of ADA, IFX failure to respond and discontinuation in patients with HLADQA1\*05 variants, and that IFX in combination with immunosuppression improved clinical outcomes in wild-type genotype patients, whereas combination therapy in patients with variant genotype did not optimize clinical outcomes significantly....
Inclusion
- Participants with Crohn's disease who meet the diagnostic criteria of the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)
- Meet the indications for IFX use
- CDAI score of 220-450; age≥18 years, regardless of gender
- Participants or family members able to understand the study protocol and willing to participate in this study by providing written informed consent
Exclusion
- NUDT 15 CT and TT genotypes; previous treatment with IFX and/or other anti-TNF biologics
- Participants who are proposed to have given birth and/or breastfeeding in the 12 months
- those with immunosuppressive intolerance or contraindications
- concurrent chronic diseases or factors of other systems (including severe cardiopulmonary, hepatic and renal, neurological, psychiatric, rheumatic and immune diseases, alcoholism, drug dependence, other chronic active diseases and long-term hormonal or immunosuppressive drugs)
- Excluding infectious diseases (tuberculosis, etc.)
- Excluding tumor-related diseases (lymphoma, gastrointestinal tract tumors, etc.)