NCT05906576RecruitingPhase 4
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 2 Jun 2023
- Start date
- 21 Sept 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Diseases
- Crohn's disease
- NCT number
- NCT05906576
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 21 Sept 2023 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who accept other anti-TNF-α any biological drugs or any other biologicals.
- Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
- Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
Other illness
- 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.
Other
- The investigator judges the subject inappropriate to be included in this study.
Who the study is looking for
- 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.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.