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

NCT07564505 | Not Yet Recruiting Phase 4

• 1 other identifier: ADM-IV-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Weeks 12, 26, 52

• Proportion of patients with clinical response

  Weeks 12, 26, 52

• Changes in C-reactive protein (CRP) levels

  Weeks 12, 26, 52

• Changes in fecal calprotectin (FC) levels

  Weeks 12, 26, 52

• Effective trough concentration of adalimumab

  week 4

Study Arms (1)

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.

Drug: Adalimumab Solution for Injection

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.

Adalimumab Solution for Injection 20mg/40mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Lanlan Geng, Doctor

CONTACT

18902268612; 13622237569@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-02