HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease
Phase 4 · Testing Azathioprine and Infliximab · Sites not listed yet · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Azathioprine (a drug) and Infliximab (a drug) as a possible treatment. Condition(s) listed: Crohn Disease and Infliximab.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 976 participants are expected to take part.
- Start date: 2023-04-30 (planned).
- Main results expected around 2026-05-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Clinical remission without corticosteroid use at 102 weeks (102 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease; Infliximab |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 976 (estimated) |
| Start date | 2023-04-30 |
| Primary completion (est.) | 2026-05-31 |
| First posted | 2023-04-14 |
| Last updated | 2023-05-09 |
| Official title | Preemptive HLADQA1*05 Genotyping for the Use of Infliximab in Chinese Crohn's Disease：A Multicenter, Prospective, Controlled, Randomized Study |
| ClinicalTrials.gov ID | NCT05813860 |
Interventions
- Azathioprine (Drug)
azathioprine in combination with Infliximab, with a dose of 1-2 mg/kg/d. - Infliximab (Drug)
5mg/kg for the first dose, and the same dose at weeks 2 and 6 after the first dose and every 8 weeks thereafter. Treatment with single Infliximab or combined azathioprine, respectively.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * 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.) * any medical condition/combined surgery/medication/other clinically significant abnormal laboratory tests which, in the judgment of the investigator, may affect the results of the test * Known refusal or inability to follow protocol requirements for any reason (including planned clinical visits and examinations)
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.