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NCT Number: NCT07564505

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

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.

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Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • (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.

Treatment and study plan

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.

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

    Time frame: Weeks 12, 26, 52

    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

Secondary outcomes

  1. Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting.

    Time frame: Weeks 12, 26, 52

    The proportion of patients achieving clinical remission (PCDAI ≤ 10 points) at 12, 26 and 52 weeks after treatment.

  2. Proportion of patients with clinical response

    Time frame: Weeks 12, 26, 52

    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

  3. Changes in C-reactive protein (CRP) levels

    Time frame: Weeks 12, 26, 52

    The changes in C - reactive protein (CRP) compared to the baseline level at 12, 26 and 52 weeks after treatment.

  4. Changes in fecal calprotectin (FC) levels

    Time frame: Weeks 12, 26, 52

    The changes in fecal calprotectin (FC) compared to the baseline level at 12, 26 and 52 weeks after treatment.

  5. Effective trough concentration of adalimumab

    Time frame: week 4

    The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks).

  6. Growth and development of pediatric patients-Weight

    Time frame: Weeks 12, 26, 52

    Weight status of children's growth and development at Week 12, 26 and 52 after treatment .

  7. Growth and development of pediatric patients-Height

    Time frame: Weeks 12, 26, 52

    Height status of children's growth and development at Weeks 12, 26 and 52 after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Lanlan Geng, Doctor

CONTACT

[email protected]

18902268612

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.