Pediatric Psoriasis
Conditions
Interventions
Anjianning (Adalimumab Biosimilar) :Standard dose (administered according to the patients weight): 1. The patient weighs 15kg to 30kg, and the first dose of Anjianning is 20mg, and then the dosage is
40 mg subcutaneously every two weeks starting one week later. Those who continue treatment with Anjianning will be followed until discontinuation of the drug, up to the 52nd week.
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
4 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Subjects aged >=4 years and =15 kg; 4.Based on the subject's previous diagnosis and confirmation by the investigator, the subject must have a history of plaque psoriasis (guttate and plaque types) for at least 6 months; 5. Subjects who have shown no response to previous topical treatments; 6.Subjects who require systemic therapy to control their disease and meet any of the following criteria: (1)Physician's Global Assessment (PGA) >=4; (2)Psoriasis Body Surface Area (BSA) >20%; (3)Very thick lesions with BSA >10%; (4)Psoriasis Area and Severity Index (PASI) >2; (5)PASI >10 and meeting at least one of the following: 1)Active psoriatic arthritis unresponsive to nonsteroidal anti-inflammatory drugs (NSAIDs) 2)Facial involvement 3)Clinically relevant genital involvement 4)Clinically relevant hand and/or foot involvement 5)Children's Dermatology Life Quality Index (CDLQI) >10 For 7.If subject is = 12 years of age, subject must have failed to respond, be intolerant, or have a contraindication to phototherapy, or is not a suitable candidate for phototherapy.
Exclusion criteria
Exclusion criteria: 1.Patients who have contraindications to Anjianning® treatment according to the drug; 2.Patients whom the investigator considers unsuitable for the trial drug due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects Achieving PASI75; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Subjects Achieving PASI 90;Percentage of Subjects Achieving PASI 100;Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) Score;Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score;Percentage of Subjects Achieving PGA "Clear" (0) or "Almost Clear" (1); | — |
Countries
China
Contacts
Public ContactXinghua Gao
The First Affiliated Hospital of China Medical University
Outcome results
None listed