Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods
Observational · No treatment assigned · 1 site · Nanfang Hospital, Southern Medical University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require…
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2025-03-02 (planned).
- Main results expected around 2025-12-31 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- plasma concentration (During hospitalization for biologic injections，an average of 1 week)
In the researchers’ words
In recent years, biologics (such as infliximab, adalimumab, vedolizumab, and ustekinumab) have shown great potential in the treatment of inflammatory bowel disease (IBD), transforming the traditional treatment model for IBD. Despite achieving good efficacy, some patients do not respond to biologics, which may be related to low drug concentrations in the blood.
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 | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Nanfang Hospital, Southern Medical University |
| Enrollment | 60 (estimated) |
| Start date | 2025-03-02 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2025-02-27 |
| Last updated | 2025-02-27 |
| Official title | Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods |
| ClinicalTrials.gov ID | NCT06849739 |
Interventions
- biologic therapy(eg:IFX,ADA,UST,VDZ) (Drug)
This study compares the detection of blood samples from IBD patients after biologic therapy(eg:IFX,ADA,UST,VDZ) using different methods
Full eligibility criteria (from the record)
Inclusion Criteria: * Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) . Exclusion Criteria: * Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| NanFang Hospital of Southern Medical University | Guangzhou, Guangdong | China |
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.