ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This trial studies adalimumab safety and pediatric dosing in children with moderate–severe Crohn's disease, which is directly relevant to families and clinicians considering anti-TNF therapy for pediatric IBD.
Who Should Pay Attention
Pediatric patients with Crohn's disease and their caregivers, pediatric gastroenterologists, and researchers studying pediatric IBD treatments and drug safety.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment30 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
A Phase 4 interventional trial is recruiting in China to evaluate Taibowei® (adalimumab) injections in children aged 6–17 with moderate to severe Crohn's disease. The study plans to enroll about 30 pediatric patients and focuses on safety outcomes (AEs, ADRs, AESIs, and serious ADRs) at 12, 26, and 52 weeks after treatment.
Dosing follows weight-based pediatric regimens (loading doses then maintenance every 2 weeks) with the option to increase frequency to weekly based on therapeutic drug monitoring and/or clinical response. The protocol requires prior prescription of adalimumab by the treating physician and excludes recent live-vaccine recipients and those in other trials.
The trial is listed as Phase 4 and recruiting at Guangzhou Medical University (Women and Children's Medical Center), China. This record is a trial registry entry describing planned safety monitoring and dosing; it does not report trial results.
Keep In Mind
This is a registry entry (Phase 4, interventional) describing a planned study and safety outcomes; it does not present efficacy or safety results. The study is small (planned n=30) and located in China. Therapeutic drug monitoring is mentioned as a reason to escalate dosing frequency, but the record itself is a protocol, not an analysis of outcomes.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Trial IDNCT07564505
Study typeInterventional
Trial phasePhase 4
Enrollment30 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 10, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Pharmacometric Targets During Anti-TNF Induction and Their Association with Deep Remission in Pediatric Crohn’s Disease
The study identifies specific induction exposure targets and biomarkers tied to higher chances of deep remission at 12 months in children on anti-TNF therapy, which could inform earlier dose optimization to improve...
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Patients and clinicians are interested in whether combining two targeted biologic therapies can induce stronger endoscopic healing for people with difficult-to-treat Crohn's disease, and whether benefit can be maintained...
Escalating Crohn's Care: The Case for Dual Therapy - Medscape
Combination (dual) therapy is an active area of research because many people with Crohn’s disease don’t achieve lasting remission on a single advanced therapy. New trials suggest some combinations may improve remission...