Post - Marketing Case Registration Study on the Safety and Efficacy of Adalimumab Solution for Injection in Chinese Pediatric Patients With Moderate - to - Severe Active Crohn's Disease

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07564505
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab Solution for Injection 20mg/40mg
    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.

Primary Outcome Measure

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 [ Time Frame: Weeks 12, 26, 52 ]

Central Contacts