This study is a real-world clinical study of adalimumab. The project plans to enrol 30 participants and aims to evaluate the efficacy and safety of adalimumab in Chinese children with plaque psoriasis, with the primary endpoint being the proportion of participants achieving PASI 75 (PASI score reduction ≥75% from baseline) at week 16.
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. In March 2020, adalimumab was approved in China for the treatment of severe plaque psoriasis in children and adolescents aged four years and older who have not responded well to topical therapies and phototherapy or are unsuitable for such treatments.
Psoriasis Area and Severity Index 75 at week 16
The proportion of subjects achieving PASI 75 at week 16 (PASI score decreased by ≥75% from baseline).
Time frame: Week 16
Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52
Proportion of subjects achieving PASI 75 at weeks 8, 32, and 52
Time frame: Week 8, Week 32, Week 52
Psoriasis Area and Severity Index 90
Proportion of subjects achieving PASI 90 (PASI score decreased by ≥90% from baseline) at weeks 8, 16, 32, and 52
Time frame: Week 8, Week 16, Week 32, Week 52
Psoriasis Area and Severity Index 100
Proportion of subjects achieving PASI 100 (100% reduction in PASI score from baseline) at Weeks 8, 16, 32 and 52
Time frame: Week 8, Week 16, Week 32, Week 52
Achieve a Physician's Global Assessment (PGA) score of clear (0) or very mild (1)
Proportion of subjects who achieved a PGA score of clear (0) or almost clear (1) at weeks 8, 16, 32, and 52
Time frame: Week 8, Week 16, Week 32, Week 52
Children's Dermatology Life Quality Index (CDLQI) score
The changes from baseline in the Children's Dermatology Life Quality Index (CDLQI) score at Weeks 8, 16, 32 and 52 were used to assess efficacy.
Time frame: Week 8, Week 16, Week 32, Week 52
Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs
Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs
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Time frame: Up to 54 weeks