A Phase 4 interventional study of Adalimumab Solution for Injection in Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 4, Interventional, and Treatment
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 320 studies on the registry; 76 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Adalimumab Solution for Injection
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.
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
Time frame: Weeks 12, 26, 52
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Weeks 12, 26, 52
Effective trough concentration of adalimumab
The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks).
Time frame: 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 .
Time frame: 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.
Time frame: Weeks 12, 26, 52
Started Aug 2026 (actual). Primary completion is estimated for Mar 2029, 31 months after the start.
Of 70 phase 4 interventional studies under Crohn Disease, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 68. This study's planned 31 months is below that.
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Studies of the drug tested here: Adalimumab
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. →