Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Phase 4 · Testing Infliximab · 1 site · Taizhou Mabtech Pharmaceutical Co.,Ltd
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab (a drug) as a possible treatment. Condition(s) listed: Crohn Disease.
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 6 to 17
- Any sex
Some of the main requirements, copied from the record:
- Age ranged 6 to 17 years (both inclusive), no gender limitation.
- A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
- Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
- The patient received infliximab for the first time.
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- The study has 1 group.
- Start date: 2023-09-21.
- Main results expected around 2026-11 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Groups in this study
- Infliximab (listed as: experimental group)
Main thing being measured
- Clinical response rate at 14 weeks (up to 14 weeks)
In the researchers’ words
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
Words you might see
- Anti-TNF: a group of biologic medicines (such as infliximab or adalimumab) used in IBD.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
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 | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Taizhou Mabtech Pharmaceutical Co.,Ltd |
| Enrollment | 30 (estimated) |
| Start date | 2023-09-21 |
| Primary completion (est.) | 2026-11 |
| First posted | 2023-06-18 |
| Last updated | 2026-09-30 |
| Official title | Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients |
| ClinicalTrials.gov ID | NCT05906576 |
Interventions
- Infliximab (Drug)
Infliximab in the treatment of Crohn's disease in children
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Age ranged 6 to 17 years (both inclusive), no gender limitation. 2. A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition). 3. Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations. 4. The patient received infliximab for the first time. Exclusion Criteria: 1. Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product. 2. Those who accept other anti-TNF-α any biological drugs or any other biologicals. 3. Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period 4. Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF 5. The investigator judges the subject inappropriate to be included in this study.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | China | Recruiting |
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.