Crohn'sRecruiting
A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
Phase 4 · Testing Adalimumab Solution for Injection · 1 site · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Adalimumab Solution for Injection (a drug) as a possible treatment. Condition(s) listed: Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's 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 is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender.
- Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the "Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019".
- (3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks/benefits.Both the patient and their guardian must sign the informed consent form. The research…
There are also 3 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.
- Start date: 2026-08-13.
- Main results expected around 2029-03 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- The incidence of adverse events (AE), adverse drug reactions (ADR), adverse events of special interest (AESI) and serious ADR at 12, 26 and 52 weeks after treatment (Weeks 12, 26, 52)
In the researchers’ words
This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.
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 | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease |
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Enrollment | 30 (estimated) |
| Start date | 2026-08-13 |
| Primary completion (est.) | 2029-03 |
| First posted | 2026-05-04 |
| Last updated | 2026-09-10 |
| Official title | Post-marketing Case Registration Study on the Safety and Efficacy of Taibowei® Adalimumab Injection for Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease |
| ClinicalTrials.gov ID | NCT07564505 |
Interventions
- Adalimumab Solution for Injection (Drug)
Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis.
Full eligibility criteria (from the record)
Inclusion Criteria: * Age is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender. * Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the "Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019". * (3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks/benefits.Both the patient and their guardian must sign the informed consent form. The research protocol/informed consent form used for data collection and data verification should comply with local laws and regulatory requirements. Exclusion Criteria: * (1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection. * (2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period. * Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Women and Children's Medical Center, Guangzhou Medical University | Guangzhou, Guangdong | 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.