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Preemptive HLADQA1*05 Genotyping for the Use of Infliximab in Chinese Crohn's Disease:A Multicenter, Prospective, Controlled, Randomized Study
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. Therefore, we believe that the impact of HLADQA1\*05 on the efficacy of IFX in the Chinese population is unclear, and the combination of immunosuppressants in patients with variant HLADQA1\*05 genotype remains to be validated due to insufficient sample size. We hypothesized that HLADQA1\*05 wild-type CD patients would have better clinical remission when treated with IFX than HLADQA1\*05 variant patients and that the combination of immunosuppressants would improve the outcome in wild-type patients but not in variant patients. By advancing this project, we hope to provide high quality evidence on the clinical use of IFX in Crohn's disease in the Chinese population and help physicians to be more selective in the use of IFX alone or in combination with azathioprine, or to switch treatment in a timely manner.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
April 30, 2023
Primary Completion Date
May 31, 2026
Completion Date
October 31, 2026
Last Updated
May 9, 2023
976
ESTIMATED participants
Azathioprine
DRUG
Infliximab
DRUG
Lead Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
NCT07245394
NCT07089420
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