A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-17
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Subjects and their guardians must sign an informed consent form. The research protocol/informed consent form for data collection and data verification should comply with local laws and regulations.
Age 4 years ≤ age ≤ 17 years, regardless of gender;
Subjects weigh ≥ 15kg;
Subjects who respond poorly to local treatment and/or phototherapy or are unsuitable for such treatments;
Disqualifiers
Based on the prescribing information of Adalimumab Solution for Injection and the judgment of the treating physician, the subject is not eligible for treatment with Adalimumab Solution for Injection;
Subjects who received psoralen combined with long-wave ultraviolet (UVA) therapy within 14 days prior to the screening period, or topical medium-wave ultraviolet (UVB) therapy within 7 days prior to the screening period;
Subjects who received non-biological systemic treatments for paediatric psoriasis within 14 days prior to the screening period;
Subjects who are currently using or have used other biological Disease-Modifying Antirheumatic Drug treatments within 12 weeks prior to the screening period;
Trial design
Treatments tested in this trial
- Adalimumab Solution for Injection
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov