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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGThe 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
Time frame: Weeks 12, 26, 52
Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting.
The proportion of patients achieving clinical remission (PCDAI ≤ 10 points) at 12, 26 and 52 weeks after treatment.
Time frame: Weeks 12, 26, 52
Proportion of patients with clinical response
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
Time frame: Weeks 12, 26, 52
Changes in C-reactive protein (CRP) levels
The changes in C - reactive protein (CRP) compared to the baseline level at 12, 26 and 52 weeks after treatment.
Time frame: Weeks 12, 26, 52
Changes in fecal calprotectin (FC) levels
The changes in fecal calprotectin (FC) compared to the baseline level at 12, 26 and 52 weeks after treatment.
Time frame: Weeks 12, 26, 52
Effective trough concentration of adalimumab
The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks).
Time frame: week 4
Growth and development of pediatric patients-Weight
Weight status of children's growth and development at Week 12, 26 and 52 after treatment .
Time frame: Weeks 12, 26, 52
Growth and development of pediatric patients-Height
Height status of children's growth and development at Weeks 12, 26 and 52 after treatment.
Time frame: Weeks 12, 26, 52
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