Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's DiseasePhase 4NCT07564505
A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
A Phase 4 study testing Adalimumab Solution for Injection in people with Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease
- What is being tested?
- Adalimumab Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2026to Mar 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, 510600
Lanlan Geng, Doctor, 18902268612, 13622237569@163.com
About this study
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
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.
- Being tested
- Adalimumab Solution for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab Solution for InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab Solution for Injection 20mg/40mg | Experimental | For children with a body weight of ≥ 40 kg, the recommended loading dose is 160 mg. Then, 80 mg is given 2 weeks later, and subsequently, 40 mg is administered every 2 weeks for maintenance treatment.
For children with a body weight of 17 - 40 kg, the loading dose is 80 mg. 40 mg is given 2 weeks later, and then 20 mg is administered every 2 weeks for maintenance treatment.
If necessary, the dosing frequency can be increased to once a week according to the results of therapeutic drug monitoring and/or clinical response. Receives: Drug: Adalimumab Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The incidences 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
Measured: Weeks 12, 26, 52
Secondary outcomes (7)
Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting.
The proportion of patients achieving clinical remission (PCDAI ≤ 10 points) at 12, 26 and 52 weeks after treatment.
Measured: Weeks 12, 26, 52
Proportion of patients with clinical response
The proportion of patients with clinical response (PCDAI score decreased by ≥ 15 points compared to the baseline) at 12, 26, and 52 weeks after treatment
Measured: Weeks 12, 26, 52
Changes in C-reactive protein (CRP) levels
The changes in C - reactive protein (CRP) compared to the baseline level at 12, 26 and 52 weeks after treatment.
Measured: Weeks 12, 26, 52
Changes in fecal calprotectin (FC) levels
The changes in fecal calprotectin (FC) compared to the baseline level at 12, 26 and 52 weeks after treatment.
Measured: Weeks 12, 26, 52
Effective trough concentration of adalimumab
The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks).
Measured: week 4
Growth and development of pediatric patients-Weight
Weight status of children's growth and development at Week 12, 26 and 52 after treatment .
Measured: Weeks 12, 26, 52
Growth and development of pediatric patients-Height
Height status of children's growth and development at Weeks 12, 26 and 52 after treatment.
Measured: Weeks 12, 26, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start13 Aug 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564505
- Sponsor's protocol ID
- ADM-IV-01
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No