Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease
Conditions
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.
Interventions
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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting. | Weeks 12, 26, 52 | The proportion of patients achieving clinical remission (PCDAI ≤ 10 points) at 12, 26 and 52 weeks after treatment. |
| Proportion of patients with clinical response | 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 |
| Changes in C-reactive protein (CRP) levels | Weeks 12, 26, 52 | The changes in C - reactive protein (CRP) compared to the baseline level at 12, 26 and 52 weeks after treatment. |
| Changes in fecal calprotectin (FC) levels | Weeks 12, 26, 52 | The changes in fecal calprotectin (FC) compared to the baseline level at 12, 26 and 52 weeks after treatment. |
| Effective trough concentration of adalimumab | week 4 | The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks). |
| Growth and development of pediatric patients-Weight | Weeks 12, 26, 52 | Weight status of children's growth and development at Week 12, 26 and 52 after treatment . |
| Growth and development of pediatric patients-Height | Weeks 12, 26, 52 | Height status of children's growth and development at Weeks 12, 26 and 52 after treatment. |
Countries
China
Contacts
CONTACTLanlan Geng, Doctor
Outcome results
None listed